(Please go to the website and "recommend" my comment. It is now a 'reader's pick' with 26 votes! Thanks!)
(Please go to the website and "recommend" my comment. It is now a 'reader's pick' with 26 votes! Thanks!)
Popcorn is just a metaphor for the larger issues! FDA rules on implanted medical devices are mired in the 1970's, though joint replacement is the #1 expenditure of Medicare. The Institute of Medicine (7/29/11) and Consumers Union have reported that the current regulations (510k)do not require pre-market clinical testing, no investigative follow-up to adverse event reports, no post-market registry and no stakeholder voting representation by patients does not fulfill the FDA mission of selecting safe and effective implanted medical devices for patients. This loophole allows the profitable medical device industry to continue to sell and implant defective products and block true innovative products. The FDA is underfunded and is lead by bureaucrats that have the dual & conflicting role of defending a wounded agency and putting up a smoke-screen to appear to be making scientific decisions. It is not working and with 25 cents of every dollar spent on products being FDA cleared, federal public policy (via Congress) must be updated. Failed implanted devices place patients in medical and legal purgatory and burden taxpayers as they absorb the costs of failed devices since the industry is legally fire walled from accountability.
April 2, 2012
White House and the F.D.A. Often at Odds
Nancy-Ann DeParle, the whip-smart and sometimes caustic White House deputy chief of staff, picked up The Wall Street Journal one summer day in 2010 and got an unwelcome shock. The Food and Drug Administration was proposing as part of the new health care law to require that movie theaters post calorie counts for popcorn — and this was the first she had heard of it.
In the F.D.A.’s view, the law called for moviegoers to know that many a buttery bucket of popcorn had more calories than two Big Macs, but Ms. DeParle, President Obama’s chief health adviser, thought the requirement was unnecessary and would probably be lampooned on Fox News as an especially silly example of the government intrusions that conservatives often mocked as the nanny state.
Dr. Margaret A. Hamburg, the F.D.A. commissioner appointed by Mr. Obama, soon heard about the White House’s displeasure and called Ms. DeParle at home one evening, people with knowledge of the call confirmed. The women had a decidedly chilly conversation. Within days, the F.D.A., an agency charged with protecting public health, backed down and dropped the notion of calorie counts for foods served in movie theaters and on airplanes.
Similar tussles have erupted between top administration officials and the F.D.A. over issues from the regulation of sunscreens and asthma inhalers to the enforcement of an agency decision on a drug to prevent premature births.
Should makers of lotions that do not prevent skin cancer be prohibited from calling them sunscreens, as the F.D.A. advocated, or should the lotions just be labeled ineffective, as the White House insisted? Should regulators weigh the cost of a drug or only the drug’s efficacy and safety?
The internal clashes over F.D.A. policy played out against a broader backdrop of regulatory politics. Republicans have made the charge that Mr. Obama is an overzealous and job-killing regulator — a central element of their case against his re-election. And on issues from clean air to investor protections, the White House has been carefully calibrating its election season positions.
In December, Kathleen Sebelius, the secretary of health and human services, drew criticism that she had put politics ahead of science when she overruled an agency decision that would have allowed over-the-counter sales of a contraceptive that helps prevent pregnancy after sexual intercourse, including to girls under age 17.
Scientists advising the F.D.A. had concluded the drug was safe and effective, but Ms. Sebelius, the reserved, no-nonsense former governor of Kansas, expressed concern that 11-year old girls might use it improperly.
It was the first time a cabinet member had ever publicly countermanded a determination by the F.D.A., the agency charged with ensuring the safety of foods and medicines. And it displayed the administration’s awareness that the politics of regulation do not always mesh with ideological or scientific judgments. An examination of these tensions shows how the Obama administration has often been more cautious on regulatory issues than the F.D.A. Its top officials — many of whom have been at the agency for decades — contend that their decisions should be divorced from politics and based solely on assessments of the science.
Three powerful women — Ms. DeParle, Ms. Sebelius and Dr. Hamburg — have been the main players in this struggle. As leading defenders of the health reform law, Ms. Sebelius and Ms. DeParle, deeply loyal to the president, have been in the political trenches. Dr. Hamburg, the polished, cerebral former head of New York City’s health department and a well-known public health advocate, has sought to balance representing the administration and the F.D.A.
Dr. Hamburg declined to respond to specific questions for this article and provided a brief written statement which stressed that the F.D.A. “will continue to work with our colleagues at the White House and across government to protect and promote the health of all Americans.” Ms. DeParle declined to comment for this article.
White House officials describe their disagreements with the F.D.A. as part of the normal, constructive give-and-take over policy that has never undermined the agency’s mission.
“Under President Obama’s leadership, the Food and Drug Administration has new authority and resources to help stop kids from smoking, protect our food supply and approve more affordable prescription drugs,” said the White House press secretary, Jay Carney.
The administration also views the agency’s hostility to its oversight as hopelessly naïve, given a 24-hour news cycle and a ferocious political environment that punishes any misstep.
“They want a world that doesn’t exist anymore,” an administration official said.
Consumer advocates credit the Obama administration with bolstering the F.D.A.’s budget and championing landmark legislation that strengthened the agency’s authority to regulate food and tobacco. But they also express concerns that the administration has been overly cautious, sitting on important regulatory policies regarding foods and medical devices to avoid giving Republicans fodder for attacks.
And some analysts worry that the administration’s increased engagement could erode the F.D.A.’s reputation for regulatory thoroughness and integrity.
“In a globalizing world, where trust is a huge part of what American manufacturers have to sell, the politicization of the F.D.A. could hurt not only consumer protection but industry profits as well,” said Daniel Carpenter, an F.D.A. historian at Harvard University. “If this trend continues, one could easily see major government purchasing programs in Europe, India, China and elsewhere saying, ‘We’re not going to follow F.D.A. recommendations anymore.’ ”
The tensions between the White House and the F.D.A. are also a window on Mr. Obama’s governing style. The White House is concerned about managing its message, and news reports or announcements — even mundane ones — that catch advisers unaware lead to sharp rebukes, according to health officials across the government.
“The White House wants to know everything, but telling everything takes a huge amount of work,” a health official at the Centers for Disease Control and Prevention said. “And in the end, it can’t really be done.”
When the F.D.A. was considering in 1999 whether to approve the hugely controversial abortion drug RU-486, Dr. Jane E. Henney, the agency’s commissioner at the time, went to a routine meeting with her boss, Donna E. Shalala, the Clinton administration’s health secretary. Dr. Henney advised Ms. Shalala that the F.D.A. would use its usual product approval process regarding RU-486, which would mean that neither Ms. Shalala nor any other administrative official outside the agency would have access to information about its review and decision or any say in the matter.
“I get it,” Ms. Shalala said, according to accounts from her and Dr. Henney in recent interviews. “We need to keep the White House and everyone else away from you, and you have my absolute assurance that will happen.”
Congress gave the power to regulate food, drugs and other health products to the nation’s health secretary, but that authority was for decades delegated almost wholly to the F.D.A., which jealously guarded its independence.
The George W. Bush White House began more closely supervising the F.D.A. Republicans were critical of government regulations, and no agency issued more rules with greater influence over daily life than the F.D.A., which oversees foods, drugs, tobacco, cosmetics and other products that account for 25 cents of every dollar consumers spend.
The Bush administration repeatedly stopped the agency from issuing rules to prevent contamination of eggs, produce and other foods, though both industry and consumer groups agreed they were needed as the death toll rose from such incidents. Mr. Bush’s health department also demanded that it approve all agency press releases.
Much of the agency’s staff assumed that the Obama administration would restore the agency’s independence.
A Turning Point
A decision that had nothing to do with the F.D.A. proved the turning point in the agency’s relationship with the White House. In the midst of the bitter 2009 battle to pass a law to provide health care to tens of millions of uninsured Americans, the United States Preventive Services Task Force announced in November that most women should not get routine mammograms until age 50 because the risks of the X-ray screens and surgical biopsies that often follow outweighed the benefits in younger women.
Although the task force did not consider cost in its analysis, Republicans charged that its recommendation was the start of health care rationing, an accusation given prominent play on Fox News.
“That scared the bejesus out of everybody,” a top F.D.A. official said.
The Obama administration became extremely risk averse, fearing further controversies might jeopardize the passage of health care reform, agency and administration officials said. It refused many interview requests for agency officials and scientists until the health law passed.
“To the career people, that was disappointing,” a top F.D.A. official said. “Employees here waited eight long years for deliverance that didn’t come.”
A provision of the new law required chain restaurants and “similar retail food establishments” to post calorie counts on menus, a provision championed by consumer advocates and the restaurant industry, which favored standardized rules over a hodgepodge of state and local ones.
The F.D.A.’s first draft of the guidelines — approved by the Department of Health and Human Services and the White House — stated that movie theaters, lunch wagons, trains and airlines would be included. A report about the proposal in The Wall Street Journal on Aug. 31, 2010, nevertheless caught the White House by surprise.
“This was the era of Glenn Beck, and the White House was terrified that Beck would get up and say this is all part of the nanny state,” a senior F.D.A. official said.
Beth Martino, the F.D.A.’s chief spokeswoman, was instructed to write a blog post reversing the agency’s draft guidance even before the comment period closed and did so on Sept. 8.
Consumer advocates were outraged.
“Movie theater popcorn is such a nutritional disaster that people deserve to know what they’re getting,” said Margo Wootan, director of nutrition policy at the Center for Science in the Public Interest.
An administration official denied that the White House had worried about Mr. Beck and defended the decision. “When was the last time you went to a movie theater and you said, ‘Man, I’m so excited to eat here?’ ” the official asked. But the official also noted that the administration has not made a final decision about what food establishments will be covered.
The Price Factor
Then in February 2011, the F.D.A. approved an application from KV Pharmaceutical to sell 17P, a decades-old drug used to prevent premature births. Since KV’s version, called Makena, was the only one officially approved, the F.D.A. would normally have banned the sale of cheaper unapproved ones. To the agency, the only issue was that KV’s drug offered guaranteed safety while those made by pharmacists were riskier.
For years, pharmacists had been making unapproved versions of this injectable form of progesterone for $200 to $400 for a 20-week course. Though F.D.A. officials were then not aware of any safety complaints about the pharmacy-made 17P, they worried about repeated instances over the years when other pharmacy-made drugs had been found to lack potency or be contaminated with deadly bacteria.
Once it had won F.D.A. approval, KV announced its price — $30,000 for a 20-week treatment, a hundredfold increase.
Administration officials then stepped in to halt any effort to ban pharmacy-made versions, citing the need to check an exorbitant price increase from a drug company that suddenly found itself with a monopoly, an increase that could burden women who needed the drug. The administration instructed the F.D.A. to issue a press release stating that, “at this time and under this unique situation, F.D.A. does not intend to take enforcement action against pharmacies” that make unapproved versions of 17P. Cindy Mann, the Medicaid director at the Centers for Medicare and Medicaid Services, sent a memorandum to state Medicaid programs that they were free to continue buying the cheaper versions.
An administration official said that the health department and the F.D.A. worked together on the 17P issue and that the White House was not involved.
“The notion that the statement or the action was somehow forced down F.D.A.’s throat isn’t accurate,” the administration official said.
F.D.A. officials said they had often been wrongly accused of considering price in drug approval deliberations and had always been able to reply that price was never a factor. “We can’t say that anymore,” a top F.D.A. official said unhappily.
Four months later, the White House approved a requirement that sunscreens protect equally against two kinds of the sun’s radiation, UVB and UVA, to earn the coveted designation of offering “broad spectrum” protection.
Top F.D.A. officials wanted to prohibit lotions with sun protection factors, or SPFs, of less than 15 from being called sunscreens because they do not protect against cancer or skin aging, while the administration insisted they could still be called sunscreens as long as they carried a label that said such lotions were ineffective. The F.D.A. replied that people often fail to read labels and warnings.
“It was all a personal reaction on their part,” a top F.D.A. official involved in the discussions said of White House officials. “They made it clear they used these products and they thought they were fine.”
An administration official said that as long as consumers are properly informed about the risks, they should generally be allowed to make such choices. Cass R. Sunstein, director of the White House’s Office of Information and Regulatory Affairs, advocates what he calls “libertarian paternalism,” a regulatory philosophy that encourages rather than mandates changes that improve or save lives. In a compromise Mr. Sunstein supported, the F.D.A. decided products with SPFs of 14 or lower could be called sunscreens but must carry warnings.
Some months later, the F.D.A. and the White House disagreed over whether to remove from the market the asthma medicine Primatene Mist because it contained chlorofluorocarbons or CFCs, banned by international treaty because they have been found to deplete the earth’s ozone layer. The F.D.A. had for years warned Primatene’s maker of the impending ban, but the company had not followed other inhaler makers and created a product that did not use CFCs even after an additional year’s reprieve.
Amphastar, Primatene’s maker, underwrote an expensive lobbying campaign to stop the F.D.A.’s planned ban.
More than a dozen members of the House signed a letter to the Obama administration asking for an extension of the deadline. Senators Pat Roberts of Kansas and Jim DeMint of South Carolina, both Republicans, introduced legislation that would have barred the F.D.A. from removing Primatene from the market because they said the ban was a burdensome regulation.
Such lobbying is not unusual for the F.D.A. What was unusual, several top agency officials said, was the effort by Mr. Sunstein to persuade the agency to give Primatene a reprieve. “Usually, we can ignore all the lobbying stuff. We get it all the time,” a top F.D.A. official said. “But when we get pressure from inside the administration, that’s when it gets really tough.”
Mr. Sunstein must approve new government rules. But in the case of Primatene, the law and rules were already in effect. The F.D.A. did not need his agreement and resisted his entreaties, officials said.
Mr. Sunstein would not comment for this article. An administration official said Mr. Sunstein’s brief use of Primatene many years ago had played no role in his views. Mr. Sunstein was simply asking for more information about the product’s market removal and was worried about the removal’s effects on the poor and the uninsured, the official said.
Disquiet among senior F.D.A. officials culminated in December when Ms. Sebelius overruled the agency’s decision to allow over-the-counter access to an emergency contraceptive called Plan B One-Step, a decision many public health experts saw as a politically motivated effort to avoid riling religious groups and others opposed to making birth control available to girls.
The emergency contraceptive gradually loses effectiveness the longer women wait before taking it after unprotected sex, so the case for easier access is compelling, the F.D.A. had concluded. The current requirement that those 16 and younger need a prescription means pharmacies cannot place the pills on public shelves, making access more difficult for all.
Susan Wood, a former head of the office of women’s health at the F.D.A., had resigned in 2005 to protest the Bush administration’s repeated refusal to make emergency contraceptives available without a prescription. In 2009, the White House invited Dr. Wood to attend a ceremony during which Mr. Obama signed a presidential memorandum pledging to restore scientific integrity to government decision-making and to listen to scientists “even when it’s inconvenient — especially when it’s inconvenient.”
Dr. Wood said that she feels Mr. Obama broke that promise and fears future administrations will overrule the F.D.A. in other such controversial areas.
“But I’m an optimist,” she added, “and hope that the president will find a way to stand by his promise.”