SUMMARY: A promising lung cancer treatment from Cuba is getting attention from U.S. patients, some of whom are already traveling there to try the drug in hopes of stopping their cancer from growing. American doctors can't prescribe CIMAvax because the Food and Drug Administration won't approve it until U.S. clinical trials can prove its effectiveness. Special correspondent Amy Guttman reports.
SUMMARY: In Congress, lawmakers are close to passing a major bill that would increase funding for the FDA, the NIH, and the effort to fight opioid abuse. The measure would also introduce more flexible standards for drug approvals, reducing the need for costly clinical trials. Lisa Desjardins reports and Hari Sreenivasan speaks with Sydney Lupkin of Kaiser Health News and Ed Silverman of STAT News for more.
HARI SREENIVASAN (NewsHour): While most attention has been focused on the action at Trump Tower in Manhattan, lawmakers at the U.S. Capitol are close to passing a major bill that would lead to big changes for drug approval, medical research and much more.
Lisa Desjardins kicks off our coverage with this report.
LISA DESJARDINS (NewsHour): Weeks from the end of its term, Congress is on the verge of passing a whopper of a bipartisan bill.
SEN. MITCH MCCONNELL, Majority Leader: This legislation promotes critical investments in research.
SEN. HARRY REID, Minority Leader: We're going to pass the Cures Act.
LISA DESJARDINS: A godsend to supporters, a spending spree or corporate giveaway to critics, here's a look at the 21st century medical cures bill. It is a mammoth $6 billion measure, now four major pieces of legislation packed in one, starting with a giant nearly $5 billion shot of funding to the National Institutes of Health for research.
That includes almost $2 billion for the 'Moonshot' effort led by Vice President Joe Biden to find a cure for cancer praised in a White House Web video today.
VICE PRESIDENT JOSEPH BIDEN: A lot of lives will be affected by this bill, God willing.
LISA DESJARDINS: That's one reason many Democrats are on board. Another? The bill now includes $1 billion to address the opioid epidemic. It's a national crisis that's been in funding limbo for months.
A third major piece? Mental health reform, including a new assistant secretary position for mental health and substance use.
Republican Tim Murphy, a psychologist, has pushed for this for years.
REP. TIM MURPHY (R-Pa.): This doesn't end the scourge of mental illness, but this puts us on a path to really make some substantial change and give people help.
LISA DESJARDINS: Now for what Republican leaders love, the bill's core, reforming and speeding up the Food and Drug Administration's drug approval process.
To some, that's modernization that cuts red tape, but to others it's a safety risk. And some lawmakers see it as a gift to drug companies.
Those voices are led by Massachusetts Senator Elizabeth Warren.
SEN. ELIZABETH WARREN (D-Mass.): I cannot vote for this bill. I will fight it, because I know the difference between compromise and extortion.
LISA DESJARDINS: But she is in the minority. The bill has received bipartisan support in Congress so far, and the president plans to sign it into law.
For the PBS NewsHour, I'm Lisa Desjardins.
HARI SREENIVASAN: Let's dive a little deeper now into this bill, what would change, and some of the criticisms around it.
For that, we're joined by two reporters who have covered this field extensively, Sydney Lupkin of Kaiser Health News; and Ed Silverman, senior writer with STAT News, a site covering medicine and health care.
SUMMARY: The Food and Drug Administration will begin regulating e-cigarettes and cigars the same way it regulates cigarettes and smokeless tobacco. About 2.5 million high school students or middle schoolers vaped at least once in the last month; now e-cigarettes can no longer be sold to people under 18. Hari Sreenivasan talks to Mitch Zeller of the FDA for more on the new policy.
HARI SREENIVASAN (NewsHour): There'll be no more e-cigarette and cigar sales to people under the age of 18. Federal oversight of the growing industry was announced today by the Food and Drug Administration.
(BEGIN VIDEOTAPE)
HARI SREENIVASAN: They've been around since 2006, but until now, they were largely un-regulated. E-cigarettes turn nicotine into an inhalable liquid vapor, but without the tobacco in regular cigarettes.
WOMAN: With blue e-cigs there's no tobacco only vapor.
HARI SREENIVASAN: Ads for the products tout benefits, using celebrity endorsements, like this one from actress Jenny McCarthy. In fact, there's no scientific consensus on benefits, or potential harm.
But Health and Human Services Secretary Sylvia Burwell says the industry will now be regulated, citing its rapid growth among teens.
SYLVIA BURWELL, Secretary of Health and Human Services: Between 2011 and 2015, the percentage of high school students who smoke e-cigarettes has skyrocketed over 900 percent. Meanwhile, hookah usage has risen significantly among young people and cigar smoking continues to be a problem among high schoolers. Together, that means millions of kids are being introduced to nicotine every year, a new generation hooked on a highly addictive chemical.
HARI SREENIVASAN: Manufacturers, many of them small companies, will have to undergo a lengthy federal review in order to stay on the market.
In response, Gregory Conley, president of the American Vaping Association, said today, quote, “If the FDA's rule is not changed by Congress or the courts, thousands of small businesses will close in two to three years.”
House Republicans (bough and paid for, my comment) have their own answer, a bill to curb retroactive safety reviews for e-cigarettes and cigars.
SUMMARY: The Food and Drug Administration announced Thursday that it would allow folic acid to be added to corn flour in order to prevent certain types of birth defects. The decision was a major victory for health advocates around the nation, who credit the additive with preventing some 1,300 birth defects per year. Judy Woodruff sits down with Dr. Jose Cordero of the University of Georgia for more.
JUDY WOODRUFF (NewsHour): A major health announcement in the U.S.A Today.
The Food and Drug Administration said it will permit one of the B vitamins, folic acid, to be added to corn masa flour, used in making tortillas and other favorites of Hispanic households, this to help prevent neural tube birth defects, such as spina bifida.
Folic acid has been in fortify wheat flour since 1996, and is credited with preventing some 1,300 birth defects a year. Health advocates have long petitioned to include it in corn flour as well.
For more, Dr. Jose Cordero joins us. He is professor at the University of Georgia, former director of the National Center on Birth Defects. He is currently on the board of the March of Dimes, which is one of the groups that pressed for the change.
Dr. Cordero, thank you for being with us.
What’s your reaction to this announcement?
DR. JOSE CORDERO, University of Georgia: Well, it was tremendous joy.
This is just a tremendous occasion, that, finally, after 10 years of asking for having folic acid included in corn masa flour, finally, it’s here. And it is very important, because, right now, not only in Hispanic households, but we all in the country are eating more tortilla chips than we are eating potato chips.
So, it is an important source of having folic acid that could help us prevent some very serious birth defects like spina bifida.
SUMMARY: Turing Pharmaceuticals sparked outcry when it raised the price of a single pill from $13 to $750. Judy Woodruff discusses the rising costs of prescriptions drugs with Dr. Peter Bach of Memorial Sloan Kettering Cancer Center and Dr. Thomas Stossel of Harvard Medical School.
JUDY WOODRUFF (NewsHour): Now let’s turn to the rising price of prescription drugs and outcries to do something about it.
The latest uproar began after The New York Times reported how one company, Turing Pharmaceuticals, raised the price of a drug from $13 a pill to $750. It follows headlines about the rising costs of new cancer drugs, as well as a breakthrough drug for hepatitis C that initially cost more than $80,000 for a course of treatment.
The two leading Democratic candidates for president, Hillary Clinton and Bernie Sanders, are proposing big changes, including lowering patient costs and bigger discounts for Medicare.
Now two views on this.
Dr. Peter Bach is the director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center. And Dr. Thomas Stossel is the director of translational medicine at Brigham and Women’s Hospital and a professor of medicine at Harvard Medical School.
And, gentlemen, we welcome you both.
Dr. Bach, I’m going to start with you.
Why is this happening?
DR. PETER BACH, Memorial Sloan Kettering Cancer Center: Well, it’s really that there’s no system in place the hold down drug prices, and so companies are just becoming increasingly bold, charging prices that they think the market will bear.
And Turing Pharmaceuticals and the 55-fold increase in the price of Daraprim is just a version of a company testing the market, if you will, just how high they can raise a price. But we see it across drugs, rapid inflation in the cost of drugs, not only new ones, but old ones.
JUDY WOODRUFF: Dr. Stossel, how do you explain it? It’s long been the case that there has been no system for keeping prices down. Why now?
DR. THOMAS STOSSEL, Harvard Medical School: Well, there still is no system, although people are asking for it.
Well, thank you for having me.
So, I have been in medicine for almost half-a-century, and it’s incredibly better because of the drugs that are available. So, drugs bring great value. There’s no question about it. Also, despite the fact there’s been uptake in costs in recent years, they still constitute less than, I think, 14 percent of total health care costs.
Now, in that 50 years, the price, the cost of what it takes to get a drug approved by the FDA has increased 100 times.
Filings from a lawsuit, scheduled to go to trial today in Atlantic City, describe a previously unreported lobbying campaign by McNeil Consumer Healthcare to protect its iconic painkiller.
Recently filed court documents show the makers of Tylenol planned to enlist the White House and lawmakers to block the Food and Drug Administration from imposing tough new safety restrictions on acetaminophen, the iconic painkiller’s chief ingredient.
An executive with McNeil Consumer Healthcare – which counts Tylenol as its flagship product – told the board of directors for parent company Johnson and Johnson about a campaign to “influence the FDA” and block recommendations made by an agency advisory panel in 2009.
After Dr. Janet Woodcock, the FDA’s top drug regulator, put off meeting with McNeil executives, the company’s president, Peter Luther, sent out an August 2009 email.
“We’re being too nice and too worried about stepping on FDA’s toes. It may be time to let members of Congress to put some pressure on FDA,” Luther wrote to other top executives. ”We have to make this our top priority and pull out all stops.”
Acetaminophen is considered safe when taken as directed. But in higher doses, the drug can cause liver damage and death. Studies show the drug is the leading cause of acute liver failure in the U.S., with fatalities increasing seven-fold in the decade between 1995 and 2005 to more than 200 a year.
“’We’re going to involve key opinion leaders, and we’re going to get them to help us influence the FDA to disregard what the advisors said,’” a plaintiff’s lawyer told a New Jersey court late last month, describing the contents of internal corporate documents.
The previously unreported lobbying campaign was disclosed as part of a trial scheduled to start today in Atlantic City that promises to draw new scrutiny to McNeil’s efforts to protect its painkiller from additional regulation and disclosures about the full extent of its risks.
The case pits McNeil against Regina Jackson, a New Jersey state employee who claims she was hospitalized with elevated liver enzymes after inadvertently exceeding the daily recommended dose for Extra Strength Tylenol for a couple of days.
The Atlantic City case is being watched closely as it is the first to come to trial of more than two hundred lawsuits currently pending in state and federal courts that allege McNeil knew its drug was potentially dangerous while promoting its safety.
As detailed in a 2013 investigation by ProPublica and This American Life, McNeil has opposed warning labels, dosage restrictions and even public awareness campaigns over concerns of profitability.
At the same time, the investigation found that the FDA has delayed implementing suggestions to improve the safety of acetaminophen, taken by tens of millions of Americans every week. Though hearings began more than 38 years ago, the agency has yet to finalize regulations for the safe use of the drug.
The long-running battle between McNeil and the FDA over the safety of one of the country’s most popular painkillers has been a key focus during the run up to the trial, which is expected to last four to six weeks.
As New Jersey Superior Court Judge Nelson C. Johnson told attorneys at a hearing on Aug. 31: “I think the jury is going to learn that the margin of safety for acetaminophen may be more narrow than the public understands.”
McNeil spokeswoman Jodie Wertheim declined to comment on material divulged during the pretrial proceedings, saying the company would defend itself at trial. McNeil has contested the allegations in all the lawsuits.
“Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division is committed to providing consumers with safe and effective over-the-counter medicines and recommends consumers always read and follow the product label,” Wertheim said. “The company has acted appropriately, responsibly and in the best interests of patients regarding Tylenol, which has one of the most favorable safety profiles among OTC pain relievers.”
Skirmishes at a series of pre-trial hearings have hinted at McNeil’s methods and motives in protecting its star product. Neither attorneys for McNeil or the plaintiff responded to a request for comment on the trial.
The proposed lobbying campaign arose in response to a June 2009 meeting of more than three dozen scientists, researchers and pharmacists convened by the FDA to review the safety of acetaminophen.
The panel of independent experts endorsed a sweeping set of reforms. They recommended that the FDA reduce the total daily dose of acetaminophen, and make extra-strength pills available only by prescription.
McNeil officials viewed the recommendations as a threat to sales of Extra Strength Tylenol, according to R. Clay Milling, one of the plaintiff’s attorneys. McNeil makes about $400 million in revenue from its extra-strength line, compared with only about $14 million from regular strength Tylenol, Milling told the court, according to a transcript.
Milling, who reviewed internal McNeil documents as part of the lawsuit, told the court that a senior McNeil executive made a presentation to the Johnson and Johnson board about a plan that included contacting the White House, the Office of Management and Budget and lawmakers.
“This petitioning of the government is not just petitioning of the government. It goes right to what the heart of this case is, saving Extra Strength Tylenol, their billion-dollar product,” Milling told the judge.
The campaign’s size and effects, if any, are unclear. At the time, Johnson & Johnson did not significantly increase its spending of about $6.5 million a year on lobbying, according to records compiled by the Center for Responsive Politics.
McNeil Consumer Healthcare is listed as a separate entity only sporadically — for example, the lobbying firm Foley Hoag reported receiving $45,000 from McNeil in 2010 to contact lawmakers in the House and Senate regarding “regulation of [over the counter] drugs.”
McNeil’s over the counter drugs sales, at $4 billion last year, are a small fraction of Johnson & Johnson’s total revenues, which came to $74 billion in 2014.
OMB officials declined to comment and the White House did not respond to requests for comment. The FDA’s top drug regulator said she would not comment given the pending lawsuit.
Whether McNeil’s campaign had impact, this much is certain: Six years later, the FDA has still taken no action on the recommendations made by its advisory board to clamp down on the “persistent, important public health problem” of deaths and injuries involving over-the-counter acetaminophen. (The FDA has implemented tougher restrictions on prescription medicines containing the drug and has issued guidelines on pediatric formulations.)
An FDA spokeswoman said the agency is continuing to review its advisers’ recommendations.
“The agency strives for a timely review and decision for future actions to assure that acetaminophen-containing medicines are safe and effective for the American public,” said Andrea Fischer, a spokeswoman for the agency.
Both agency and independent scientists have expressed concerns about acetaminophen’s safety margin – the difference between what can help and what can harm.
The current recommended daily dose for the drug is four grams per day — the equivalent of eight extra strength pills. But occasional reports in scientific literature have documented liver damage occurring after taking as little as two extra pills per day for several days.
The agency has worried about the prevalence of acetaminophen on the market — McNeil and its generic competitors have developed hundreds of over-the-counter products that contain the drug, increasing the risk that a consumer could inadvertently ingest dangerous levels.
The most recent FDA data show that acetaminophen remains, by far, the leading cause of acute liver failure in the United States, with the number of cases increasing.
FDA officials have blamed the agency’s inaction largely on a system designed in the 1970s to regulate over-the-counter drugs. The process requires lengthy public debate, legal review and economic analysis to make even small changes.
After the ProPublica investigation, the FDA announced it was seeking to reform the cumbersome process.
“The law allows the FDA to handle safety issues with prescription drugs rapidly,” said Dr. Joshua Sharfstein, an associate dean at the Johns Hopkins Bloomberg School of Public Health and the former number two at the FDA. “By contrast, for over-the-counter drugs, the law generally requires a mountain of paperwork and a tortuous path through the federal government.”
At the late August pretrial hearing, Michael B. Hewes, an attorney for McNeil, acknowledged that McNeil had talked with FDA officials after the June 2009 meeting to discuss the new proposals.
His account is consistent with documents obtained by ProPublica and This American Life through the Freedom of Information Act. Only a month after the experts’ recommendations, McNeil sent a letter to Woodcock, the director of the FDA branch overseeing drugs. The first sentence requested a meeting “to establish a dialogue.”
In the letter, the company reversed several positions it had taken a month earlier before the advisory panel. For instance, McNeil offered to voluntarily add language to Tylenol products suggesting a limit of three grams per day. McNeil products currently direct consumers to take up to three grams, while maintaining that four grams per day is a safe daily limit.
But McNeil stood its ground on the experts’ recommendation to make a dose of two Extra Strength Tylenol pills available only via prescription. Any such action, McNeil warned Woodcock, would take a “significant amount of time,” citing the agency’s process.
A series of emails between executive at McNeil and Johnson & Johnson from mid-August 2009 that were read into the court record on Sept. 17 by attorneys indicate Woodcock and her aides were not ready to meet with McNeil. So the head of Johnson & Johnson’s FDA liaison office, who formerly worked as a lawyer in the FDA drug division, was planning to “reach out directly” to Woodcock in the coming days, one email said.
Luther responded with the suggestion that McNeil enlist members of Congress to press the FDA on the company’s behalf.
It is not clear what became of McNeil’s lobbying plans. But internal documents show their strategy was one part compromise and one part resistance.
The compromise, as discussed with the Johnson & Johnson board and in the subsequent letter to Woodcock, adopted one of the panel’s recommendations, lowering the daily maximum recommended dose. The FDA, in 2010, gave its blessing to that idea and it became part of Tylenol’s label by the summer of 2011.
But the company also opposed any move to have Extra Strength Tylenol fall under the more prohibitive prescription drug regimen, as the panel had recommended. The main goal, one senior Johnson & Johnson executive wrote Luther in September 2009, was to “just save” the 500-milligrams product, according to court records from last week. The medication remains an over-the-counter drug to this day.
In the six months after the 2009 advisory meeting no senior agency official, including Woodcock, indicated holding a meeting with McNeil on acetaminophen, according to the agency’s public calendar. Woodcock, through a spokeswoman, declined to comment, citing the court case.
However, Woodcock made her concerns over acetaminophen public in an opinion article in the New England Journal of Medicine in November 2009. She said the agency was considering the panel’s recommendations, which she acknowledged would have a “considerable” effect on the availability of the drug on the market.
“Although acetaminophen, when used as labeled, is generally safe, the ubiquity of the drug and its relatively narrow therapeutic index create the potential for serious harm from both inadvertent and intentional overdoses,” Woodcock wrote.
The judge, in pre-trial rulings, has said the 2009 lobbying documents will not be presented to the jury unless McNeil’s attorneys ask witnesses to discuss what happened to the advisory panel’s recommendations.
Last week, the judge asked whether the company had an “ulterior motive” in seeking to influence the FDA, as the plaintiff’s lawyers had suggested. Hewes, the McNeil lawyer, said the company’s concerns involved “unintended health consequences” if Tylenol became a prescription drug. He later went on to say that restrictions on acetaminophen would shift consumers to other painkillers, such as NSAIDs, which can have adverse gastrointestinal and other side effects.
Even without the FDA lobbying issue, McNeil’s attorneys in the Atlantic City case indicated they plan to emphasize that the company has always complied with the rules of the FDA – the agency charged with protecting the American public.
“The FDA is all over the case. I mean, all over the case,” David Kott, another lawyer for McNeil, told Johnson, the presiding judge last month.
Johnson expressed his agreement.
“We’re talking about a product that’s been on the market for 50 years and is widely used,” he told the attorneys. “Throughout that process, FDA was giving various blessings.”
SUMMARY: The FDA has ordered the complete removal of trans fats from foods within the next three years. Dr. Walter Willett the Chair of the Department of Nutrition at Harvard’s T.H. Chan School of Public Health discusses the effect this will have on Americans’ health and their favorite snacks.
GWEN IFILL (NewsHour): In health news today, the Food and Drug Administration moved to effectively ban artificial trans fats, declaring that partially hydrogenated oils, known as PHOs, and the main source of artificial trans fats, are unsafe for use in human food.
Food manufacturers have three years to get rid of the PHOs, a move the FDA said could prevent thousands of fatal heart attacks each year.
For more on today’s announcement, we turn to Dr. Walter Willett, chairman of the Department of Nutrition at Harvard University’s T.H. Chan School of Public Health.
Thank you for joining us, Dr. Willett.
If you could please start by explaining for people who don’t understand, where do they find, where do you see trans fats?
DR. WALTER WILLETT, Department of Nutrition Chairman, Harvard University’s T.H. Chan School of Public Health: Trans fats have been widely used in the food supply as a substitute for lard and butter.
We found them in shortenings? We found them in margarines, baked goods, deep-fried products. Fortunately, about 80 percent or 85 percent of trans fats have been removed from the food supply by this time.
GWEN IFILL: Well, OK, let’s talk about that, because if the FDA is just today saying that they were banned and we have already lost 80 — almost, as you pointed out, 80 percent of trans fats in the food supply since 2003, what is the need for this full ban now?
DR. WALTER WILLETT: Even the relatively small amount of trans fats remaining are still likely to be causing around 7,000 premature deaths from heart disease per year.
That’s still a large number and definitely worth the ban taking effect to really get trans fat off the table entirely.
SUMMARY: More than 30 million Americans take statins to lower their cholesterol, according to estimates. But these popular drugs don't work for everyone. Now the FDA may be poised to approve a powerful new class of drugs that can attack cholesterol levels in a different way. Hari Sreenivasan talks to Dr. Steven Nissen of the Cleveland Clinic and Dr. Harlan Krumholz of the Yale School of Medicine.
HARI SREENIVASAN (NewsHour): The FDA will decide later this summer whether to follow the panel’s recommendations. But it usually does so. And the drugs, which are injected once or twice a month, have been shown to be effective at lowering bad cholesterol in early trials.
Still, larger trials need to be completed to see if they prevent heart attacks and strokes. And then there’s the question of how many people may ultimately take them. More than 70 million Americans have high LDL. Initially, they may cost around $10,000 a year per patient.
We talk to two cardiologists about these questions.
Dr. Stephen Nissen is the chair of cardiology at the Cleveland Clinic. For the record, he is leading a study of one of the drugs and is on the steering committee for a Pfizer clinical trial. He takes no money from the companies. And Dr. Harlan Krumholz is professor of cardiovascular medicine at the Yale School of Medicine.
So, Dr. Nissen, I want to ask, why is this class of drugs so interesting to you? What does this do that the medications that are on the shelf today don’t do?
DR. STEPHEN NISSEN, Chairman, Department of Cardiology, Cleveland Clinic: Well, LDL cholesterol is the primary driver of coronary heart disease, the most important risk factor that we can modify.
And we have great drugs called statin drugs, drugs like Zocor and Lipitor and so on, that are very effective at lowering LDL cholesterol and preventing heart attack, stroke and death.
But not everybody gets an adequate response to those drugs. Some people are genetically programmed to have very high levels of bad cholesterol, LDL, and they just don’t get well enough with those drugs. And there are other people that are intolerant of the drugs.
So we have needed another class of drugs. These drugs are really powerful. They lower LDL anywhere from 50 to 70 percent. And that’s additive on top of the effects of the statin drugs. So they’re very exciting, very powerful.
SUMMARY: In May, Colorado became the first state to pass a so-called 'right to try' law, allowing terminal patients access to experimental drugs without FDA approval -- and Missouri is about to follow suit. NewsHour Weekend examines the issue by speaking with the Missouri bill's sponsor and his daughter, who is suffering from cancer.
STEPHEN FEE (NewsHour): In early 2013, Kristina Brogan was pregnant with her fifth child when she began experiencing excruciating pain — and her obstetrician didn’t know why.
KRISTINA BROGAN: Finally my mom went with me to an appointment and said you got to find out why she’s hurting so bad. So they did a level two ultrasound at St. Luke’s and admitted me immediately.
STEPHEN FEE: Why? What did they find?
KRISTINA BROGAN: They found the tumor. And they’d found it had gone up into my liver.
STEPHEN FEE: Kristina, at the age of 39, was diagnosed with stage four colorectal cancer.
STEPHEN FEE: What was that like?
KRISTINA BROGAN: Scary.
STEPHEN FEE: What was running through your head?
KRISTINA BROGAN: I can’t say I had a – a normal thought in my head. I was just scared. Scared for my baby. Scared for me. Scared for my family.
STEPHEN FEE: Her doctors needed to take aggressive measures to fight the disease and chose to perform a C-section, just 28 weeks into Kristina’s pregnancy. Today, her son Evan is a happy and healthy one-year old. Kristina however is battling a disease with dispiriting odds even with regular chemotherapy treatment.
JUDY WOODRUFF (NewsHour): The U.S. Food and Drug Administration announced today that it intends for the first time to regulate the ever-growing business of electronic cigarettes. Sales have grown to $3 billion a year. And some public health experts are worried about its rise.
The number of middle and high school students using e-cigarettes doubled between 2011 and 2012. Under the new rules, sales would be banned to anyone under the age of 18. Companies would have to register their products and ingredients with the FDA, but they can continue marketing to adults.
New regulations would also apply to cigars, pipe tobacco, and hookahs or water pipes, for the first time.
There are many questions about the agency’s approach.
Mitch Zeller is the director of the FDA’s Center for Tobacco Products. And he joins me now.
JUDY WOODRUFF (Newshour): For the first time in two decades, the federal government is making significant changes to the nutrition labels on the food and drinks you buy at the store.
Jeffrey Brown sorts through the details and what the changes are designed to do.
JEFFREY BROWN (Newshour): As Michelle Obama said today, unless you had a thesaurus, a microscope, a calculator, or a degree in nutrition, you were out of luck. So the new labels put forward by the Food and Drug Administration aim to reduce confusion about calories, serving sizes and more.
We get an explanation from William Dietz, former director for the CDC’s Division of Nutrition and Physical Activity.
And welcome to you.
I want to start with some props that we have to help us, a 12-ounce bottle of soda that used to be thought of as a single serving, and a 20-ounce bottle that is nowadays perhaps at the lower end of what people actually consume in a serving. How do the new labels deal with this growth in serving sizes?
DR. WILLIAM DIETZ, Former CDC Official: Well, the nutrition facts panel was originally developed about 20 to 30 years ago, at a time when servings were much smaller than they are today.
And the 12-ounce to the 20-ounce soda is a good illustration. Another good illustration is that ice cream used to be, a serving was half-a-cup, and, today, it’s a cup. So one of the most important changes in the nutrition facts panel is an updating of portion size.
JEFFREY BROWN: All right, so, now I want to show a proposed new label so we can see another way that these new labels would help. This is — this emphasizes calories, and the number of servings are given much more prominence here. This is to overcome some of the confusion?
DR. WILLIAM DIETZ: Well, twofold.
Yes, part of it is to overcome confusion. Part of it is to highlight the role of calories. The issue in the United States today is obesity. And obesity is caused by excess calories. So highlighting the caloric content of the product is an important step towards trying to control obesity.
JEFFREY BROWN: There’s also in this new proposed label at least something new. It’s a separate line for sugars that are added. Now, explain what that means and why it’s important.
DR. WILLIAM DIETZ: Well, the last two dietary guidelines, under two different administrations, 2005 and 2010, called for a reduction in the intake of added sugars by Americans.
But the prior labels didn’t have added sugars on them. Furthermore, we know that sugars are an important contributor to obesity. So highlighting added sugars gives Americans an additional piece of information on how to begin to control their weight.
JEFFREY BROWN: In thinking about how important all of this is, what — how much is known about the degree to which people actually read these labels and are guided by them?
DR. WILLIAM DIETZ: Well, my understanding is that about a third of people read those nutrition facts panels today.
But our hope is that this will get increased use. And, as the panel becomes more helpful and to helping Americans make good decisions about their nutrition, that it will receive increasing use. But it’s certainly not be-all and end-all. People make decisions for all sorts of reasons, and nutritional content is only one of those reasons.
JEFFREY BROWN: Also still on the table, but I gather delayed so far, are changes to labels on menus in restaurants and fast food stores. So that, of course, is another component of all of this.
DR. WILLIAM DIETZ: Right.
And, in my view, that’s a much more complicated business, because restaurants, the way they prepare their portions and their foods is going to be very hard to assign a nutrition facts panel too.
But, certainly, most people get their calories from those products that they buy in the grocery stores. And those products are going have the nutrition facts panel, which will enable a more educated judgment about that purchase.
JEFFREY BROWN: And, finally, the food industry and everyone actually gets to weigh in for — before all of this is set. Would you expect changes or delays to these proposed new labels?
DR. WILLIAM DIETZ: Well, I think that there’s going to be a lot of controversy about this.
The Grocery Manufacturers Association had kind of a noncommittal statement this morning about their response to these panels. But I think there’s an opportunity for both the industry and the public, most importantly the public, to respond to these changes and let the federal government know how they feel about it and whether they think this is going to be helpful.
JEFFREY BROWN: All right, William Dietz, thanks so much.
DR. WILLIAM DIETZ: You’re very welcome.
JUDY WOODRUFF (Newshour): Tarnished teeth, prematurely wrinkled skin on teenage faces, and students subjected to bullying, those are the images of a new multimedia anti-smoking campaign being launched by the U.S. Food and Drug Administration. It’s a $115 million campaign that will run in 200 markets over the course of a year, beginning next week, the goal, use ads like these to get through to younger Americans about the personal costs of cigarettes.
Kathy Crosby is the director of health communication and education at the FDA’s Center for Tobacco Products, making her a point person on this campaign.
And she joins me now.
JUDY WOODRUFF (Newshour): Let's look closer now at the government's decision to ban artificial trans fats from the American diet.
The Food and Drug Administration says those partially hydrogenated fats are not considered safe in food. Their use has declined substantially in recent years as manufacturers have increasingly removed them, but they are still consumed in significant amounts.
The director of the U.S. Centers for Disease Control, Dr. Thomas Frieden, has been a leading public health voice on this since he was health commissioner in New York City.
Dr. Frieden, thank you for being with us.
First of all, remind us, what foods contain these trans fats?
DR. THOMAS FRIEDEN, Centers for Disease Control and Prevention: Well, first off, artificial trans fats are just that. They're artificial. They don't exist in nature. And they're created by bubbling hydrogen through vegetable oil.
They make oil solid at room temperature. Unfortunately, it also makes that oil solid in your coronary arteries and increases your risk for a heart attack. The food industry has done a great job. They have gotten about half -- a little more than half of the trans fats out of the system, but there's still a lot in the system.
We're able to measure that in the studies we do in people throughout the U.S. And it continues in a variety of products, either in low concentrations or some in higher concentrations in things like frosting and some prepared foods.
When Heather Dougherty heard the news last week that the Food and Drug Administration had recommended tightening how doctors prescribed the most commonly used narcotic painkillers, she was overjoyed. Fourteen years earlier, her father, Dr. Ronald J. Dougherty, had filed a formal petition urging federal officials to crack down on the drugs.
Dr. Dougherty told officials in 1999 that more of the patients turning up at his clinic near Syracuse were addicted to legal narcotics like Vicodin and Lortab that contain the drug hydrocodone than to illegal narcotics like heroin.
Since then, narcotic painkillers, or opioids, have become the most frequently prescribed drugs in the United States and have set off a wave of misuse, abuse and addiction. Experts estimate that more than 100,000 people have died in the last decade from overdoses involving the drugs. For his part, Dr. Dougherty, who foresaw the problem, retired in 2007 and is now 81 and living in a nursing home.
“Too many lives have been ruined,” his daughter said.
The story behind the F.D.A.’s turnaround on the pain pills, last Thursday, involved a rare victory by lawmakers from states hard hit by prescription drug abuse over well-financed lobbyists for business and patient groups, one that came during a continuing public health crisis.
Just last year, Representative Fred Upton, Republican of Michigan — the House’s biggest recipient during the last election cycle of drug industry campaign contributions, with nearly $300,000 — blocked a measure that would have imposed the restrictions the F.D.A. backed last week.
Among the provisions in the bill, pushed by Senator Joe Manchin III, Democrat of West Virginia, was one that is central to the new F.D.A. recommendations: reducing to 90 days the length of time in which a patient could obtain refills for painkillers containing hydrocodone without a doctor visit. The drugs are now widely sold by generic producers.
Mr. Upton, who is the chairman of the House Energy and Commerce Committee, argued that imposing new limits would harm patients who needed the drugs, which are used to treat pain from injuries, arthritis, dental extractions and other problems. That stance was echoed by patient groups, lobbyists representing drug makers, pharmacy chains like Walgreens and CVS, local drugstores and physicians groups like the American Medical Association.
The F.D.A.’s long resistance to added restrictions on the drugs underscores what critics say is its continuing struggle to address the complexities of the painkiller problem in its often conflicting roles — one as a regulator that approves drugs and the other as a drug safety watchdog.
On Friday, public health advocates who had cheered the agency’s decision the day before were dismayed when the F.D.A. approved a new, high-potency painkiller despite an 11-2 vote by an expert panel of its own advisers not to do so. The panel concluded in December that the long-acting opioid, called Zohydro, could lead to the same type of abuse and addiction as OxyContin.
SUMMARY: While millions of people use prescription painkillers for relief, their abuse has reached epidemic levels in some places. To combat rising addiction rates, the FDA has a new plan to limit the distribution of pain meds, specifically containing hydrocodone. Hari Sreenivasan gets more from Barry Meier of The New York Times.
JEFFREY BROWN (Newshour): And we return to the battle over emergency contraception, the so-called morning after pill.
It's been more than a decade since the pill was first approved by the FDA, but legal and political controversy has swirled ever since. In 2011, the FDA decided the drug should be available to all girls and women, without prescription.
In an unprecedented action, Health and Human Services Secretary Kathleen Sebelius quickly overruled the agency, keeping the age limit at 17 and older.
Last month, a federal judge ordered that restriction lifted in a strong rebuke to the administration.
And then, on Tuesday, the FDA set a new age limit, 15 and older, for the most popular version of the pill, known as Plan B One-Step. And last night, the Department of Justice said it will fight the federal judge's broader decision that the drug should be available to all girls and women.
Julie Rovner of NPR is here to help sort it all out.
A federal judge on Friday ordered the U.S. Food and Drug Administration to make "morning-after" emergency contraception pills available without a prescription to all girls of reproductive age, while blasting top Obama administration officials for interfering with the process.
The ruling in a Brooklyn court is the latest step in the years-long legal saga over the pill known as "Plan B," which has sparked political controversy.
Currently, only women age 17 or older can obtain emergency contraception pills without a prescription. Point-of-sale restrictions require that all women present identification to a pharmacist before obtaining the drug.
In his ruling, U.S. District Judge Edward Korman said the FDA's rejection of requests to remove age restrictions was "arbitrary, capricious and unreasonable."
FDA spokeswoman Erica Jefferson declined to comment on the ruling, saying it was an ongoing legal matter.
The Center for Reproductive Rights and other groups had petitioned the FDA to strike down age and access limits, saying there was no scientific proof that girls younger than 17 could not safely use the drug without supervision.
Nancy Northup, president of the Center for Reproductive Rights, hailed the ruling. "Women all over the country will no longer face arbitrary delays and barriers just to get emergency contraception," she said.
The ruling is also likely to be well received by medical groups like the American Academy of Pediatrics, which recommended last year that pediatricians write advance prescriptions for patients under 17.
But opponents of abortion decried the ruling and warned that the pill's widespread availability could spur criminal activity.
"When these are right out there with the bubble gum, they're going to be part of the date rape cocktail," said Karen Brauer, president of Pharmacists for Life.
Some pharmacists across the United States have refused to dispense emergency contraceptives because it violates their religious faith. Making the pills available over the counter removes the pharmacist's role in dispensing the drug, which Brauer welcomed.
POLITICAL CONTROVERSY
Teva Pharmaceuticals Ltd's Plan B in 1999 became the first emergency contraceptive available for prescription use in the United States. The company also markets Plan B One-Step, a one-pill version of Plan B.
"Teva has received the Court's decision and we are currently reviewing it," said company spokeswoman Denise Bradley. "We have no additional comment at this time."
Emergency contraceptives generally sell for $10 to $80. Although they can work as long as 120 hours after unprotected sex, they are most effective in the first 24 hours.
Sanford Bernstein analysts estimate Teva's 2013 sales for Plan B at just $1.5 million, though, because of generic competition like Next Choice from Actavis Inc.
In 2005 the FDA declined to approve over-the-counter sales of the drug, overruling its panel of outside experts as well as its own scientists.
In December 2011 the FDA reversed that stance and moved to approve over-the-counter sales with no age limits. But Health and Human Services Secretary Kathleen Sebelius overruled it, ordering that girls under 17 could only get the pills with a prescription.
As a result of that policy, women well beyond their teens are often asked to present proof of age to show that they are old enough to purchase the pills without a prescription, Judge Korman said.
'QUESTION HER GOOD FAITH'
In his ruling on Friday, Korman said Sebelius' actions were clearly political.
"Nevertheless, even with eyes shut to the motivation for the secretary's decision, the reasons she provided are so unpersuasive as to call into question her good faith," he wrote.
Representatives of the Department of Health and Human Services were not immediately available to comment on the ruling.
One FDA veteran praised the decision, though.
"This has been a 10-year saga during which the FDA was not allowed to do its role properly, not allowed to make science-based decisions," said Susan Wood.
Wood resigned from the FDA as assistant commissioner for women's health in 2005 over its decision not to approve over-the-counter sales of emergency contraception. She is now director of the Jacobs Institute of Women's Health at George Washington University in Washington.
"This decision gives the FDA the chance to reclaim its ability to make decisions based on science, medicine and evidence," Wood said, "not politics."
GWEN IFILL (Newshour): Finally tonight: the toll of the meningitis outbreak; 32 people have died so far, and more than 400 others have become ill; 14,000 people may have been exposed to the drugs injected to ease back pain.
The state of Tennessee was especially hard-hit, with 13 deaths.
Newshour health correspondent Betty Ann Bowser has a look at the personal impact there and the bigger questions surrounding this story.
BETTY ANN BOWSER (Newshour): Diana and Wayne Reed did everything together. They ate meals together, vacationed together, danced together, and of course, raised their two sons, Erik and Kevin, together.
So, 27 years ago, when Wayne was diagnosed with amyotrophic lateral sclerosis, known as ALS, or Lou Gehrig's disease, they fought that together, too. Diana was Wayne's primary caregiver, so it came as a complete shock when the 56-year-old died suddenly on Oct. 3 from fungal meningitis.
It was an even bigger shock when Wayne and her friends were told Diana had been injected with a contaminated steroid medication made at a compounding pharmacy in Massachusetts. Wayne has the same rare slow growing form of ALS as physicist Stephen Hawking, so he has trouble speaking. But his mind remains sharp and has not been affected.
GWEN IFILL (Newshour): The spread of HIV -- that scientists hope will save lives, it all comes down to testing.
Of the 1.2 million Americans who carry the virus which causes AIDS, 20 percent don't even know they have it. After diagnosis, the chance that a patient treated with antiretroviral drug will transmit the disease drops by as much as 96 percent.
The Food and Drug Administration has now approved the first at-home test to detect HIV infection.
To explain how it will work, we're joined by Dr. Anthony Fauci, the director of National Institute of Allergy and Infectious Diseases.
After decades of controversy, the Food and Drug Administration approved a new H.I.V. test on Tuesday that for the first time makes it possible for Americans to learn in the privacy of their homes whether they are infected.
The availability of an H.I.V. test as easy to use as a home-pregnancy kit is yet another step in the normalization of a disease that was once seen as a mark of shame and a death sentence.
The OraQuick test, by OraSure Technologies, uses a mouth swab and gives results in 20 to 40 minutes. A previous test sold over the counter required a user to prick a finger and mail a drop of dried blood to a lab.
Dr. Anthony S. Fauci, the longtime AIDS researcher and director of the National Institute of Allergy and Infectious Diseases, called the new test a “positive step forward” and one that could help bring the 30-year-old epidemic under control.
Getting an infected person onto antiretroviral drugs lowers by as much as 96 percent the chance that he or she will transmit the virus to someone else, so testing and treatment have become crucial to prevention. About 20 percent of the 1.2 million infected Americans do not know they have the disease, the Centers for Disease Control and Prevention estimates, and about 50,000 more get infected each year.
Dr. Robert Gallo, who headed the National Institutes of Health lab that developed the first American blood test for the virus in 1984, called the F.D.A. approval “wonderful because it will get more people into care.”
The idea of a home test has long been mired in controversy. The first application for one was made in 1987, and the F.D.A. has been considering OraSure’s simple mouth-swab test since 2005.
But the history of AIDS and the human immunodeficiency virus that causes it are unique. AIDS emerged in the 1980s wrapped in a shroud of stigma. It was spread by sex, drug injections and blood transfusions. Along with hemophiliacs, heroin users and Haitians, the most vocal group of early victims was gay men, who were then in the throes of a loud and defiant liberation movement.
Because merely being tested for H.I.V. was seen as tantamount to being publicly revealed as gay or addicted to drugs, and because an H.I.V.-positive result was a death sentence, groups like the Gay Men’s Health Crisis and newspapers like The New York Native advised their members and readers to shun testing until ironclad guarantees of anonymity were put in place.
Alarmists predicted a wave of suicides if home tests were made available. At hearings, advocates for AIDS patients handed out copies of an obituary of a San Francisco man who jumped off the Golden Gate Bridge after learning he was infected. C.D.C. officials warned their F.D.A. counterparts that home testing could lead to a surge of new patients that would swamp overburdened health clinics, according to an F.D.A. document.
So, even as tests for other stigmatized diseases like syphilis were once part of getting a marriage license and home pregnancy kits became available at every corner pharmacy, H.I.V. tests lived in a special limbo, usually requiring a counseling session and the signing of a consent form, adding to the air of dread.
Even when antiretroviral drugs emerged in the mid-1990s, states were slow to rewrite laws governing testing.
Mark Harrington, the executive director of the Treatment Action Group, an AIDS advocacy organization, said in an interview that he thought such fears were “a thing of the past” now that it is clear that early treatment saves lives. “Any tool that speeds up diagnosis is really needed,” he said.
The new test has some drawbacks. While it is extremely accurate when administered by medical professionals, it is less so when used by consumers. Researchers found the home test accurate 99.98 percent of the time for people who do not have the virus. By comparison, they found it to be accurate 92 percent of the time in detecting people who do. One concern is the “window period” between the time someone gets the virus and begins to develop the antibodies to it, which the test detects. That can take up to three months.
So, while only about one person in 5,000 would get a false negative test, about one person in 12 could get a false positive.
Any positive test needs confirmation in a doctor’s office, the F.D.A. said, and people engaged in high-risk sex should test themselves regularly.
The agency does not intend for the home test to replace medical testing, but instead to provide another way for people to find out their H.I.V. status, said Dr. Karen Midthun, director of the F.D.A.’s Center for Biologics Evaluation and Research.
The home test should be available in 30,000 pharmacies, grocery stores and online retailers by October, said Douglas Michels, OraSure’s chief executive. The price has not yet been set. But he said it would be higher than the $17.50 now charged to medical professionals because the company will do more complicated packaging for the home kit, open a 24-hour question line, and advertise to high-risk groups, including gay men, blacks and Hispanics, and sexually active adults. Still, he said, it will be kept inexpensive enough to appeal to people who might want to buy several a year.
Because the F.D.A. approved the home test only for people 17 and older, retail stores may ask customers to show ID, he said. The restriction is not for medical reasons, but because only a few subjects age 14 to 16 were tested, he said, “so that was the deal we worked out with the F.D.A.”
Whether having to show identification would deter teenagers or young-looking people from buying a test is unclear. Mr. Harrington said he thought it might.
In contrast, teenage girls are not legally required to show identification to buy pregnancy tests.
In a momentary flash of bipartisanship, the Senate approved legislation that would allow Americans speedier access to generic drugs as well as breakthrough treatments for life-threatening diseases as part of a Food and Drug Administration revamping that now heads to the House.
But the comity didn't last, and the FDA accord was quickly followed by another round of partisan fighting over President Obama's push to keep student loan interest rates low. On party-line votes, senators blocked Democratic and Republican efforts to prevent interest rates from rising this summer.
The outcome of Thursday's session sends senators home for the Memorial Day recess with a toolbox for campaign season: On one hand, they can say they're working together to produce results; on the other, they can spread the blame for the partisan standoff in Congress.
"I wouldn't make too much of it, but we have had a string of legislative successes that have been bipartisan," said Sen. Michael Bennet (D-Colo.). The FDA bill was approved 96 to 1, and the House is expected to consider similar legislation next week. "We are going to pass out a very comprehensive set of reforms that are going to be meaningful to patients and also to the bio-science community."
The FDA bill includes routine financial provisions as well as new policies that supporters say could save lives by bringing new drugs and medical devices to the marketplace more quickly.
The legislation would allow the continued collection of fees agreed to by brand-name drug and medical device manufacturers — in addition to launching new fees on generic drug makers — to fund FDA review and approval of product applications.
At the same time, the legislation would allow the FDA to create a "breakthrough" designation to speed the development of drugs that "may demonstrate substantial improvement over existing therapies" for those with serious or life-threatening illness.
The bill also would tighten oversight of the drug supply chain by requiring foreign manufacturers to register additional information about their facilities with the FDA, and it would enhance penalties for drug counterfeiting. More manufacturers would be required to give six months' notice to the FDA if they discontinued certain drugs or had a supply shortage.
The fees are a key source of funding for the FDA, and failure to pass a bill before the existing authorization expires in September would result in layoffs. The bill would extend the fee agreements for five years, through fiscal 2017.
Proponents say the new fee on generic drug makers, estimated to bring in $300 million a year, would slash the time it takes to approve new drugs from 30 months to 10.
Senators rejected an effort by Sen. Richard J. Durbin (D-Ill.) to regulate nutritional supplements and another by Sen. John McCain (R-Ariz.) to loosen restrictions on Canadian drug imports.
Moments after passing the FDA bill, the Senate was squabbling again, blocking dueling measures that would prevent interest rates on new Stafford student loans from doubling to 6.8% on July 1.
Democrats and a handful of Republicans rejected the House-passed GOP proposal to gut a federal public health and prevention fund to pay for the $6-billion cost of the federal student loan subsidy.
Republicans followed suit by voting down the Democratic proposal that would close a tax loophole on wealthier households whose profits through their S corporations are not counted as income.
