Conflict within

The FDA's reputation for regulatory thoroughness is in danger of being compromised by an overbearing Obama administration.

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 (FDA) was proposing as part of the new health care law that movie theatres post calorie counts for popcorn and this was the first she had heard of it.

In the FDA's view, the law called for moviegoers to know that many a buttery bucket of popcorn had more calories than two Big Macs, but DeParle, President Barack Obama's chief health adviser, thought the requirement was unnecessary and would probably be lampooned as an especially silly example of the government intrusions that conservatives often mocked as the nanny state.

Margaret A. Hamburg, the FDA Commissioner appointed by Obama, soon heard about the White House's displeasure and called DeParle at home one evening, people with knowledge of the call confirmed. The women had a decidedly chilly conversation. Within days, the FDA, the agency charged with protecting public health, backed down and dropped the notion of calorie counts for foods served in movie theatres and on airplanes.

Similar tussles have erupted between top administration officials and the FDA over issues from the regulation of sunscreens and asthma inhalers to the enforcement of a 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 FDA advocated, or should the lotions just be labelled 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 FDA policy played out against a broader backdrop of regulatory politics. Republicans have made the charge that 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 protection, the White House has been carefully calibrating its election season positions.

Politics before science

In December, Secretary of Health and Human Services, Kathleen Sebelius, drew criticism that she had put politics ahead of science when she overruled an FDA decision that would have allowed over-the-counter sales of a contraceptive that helps prevent pregnancy after sexual intercourse, including to girls younger than 17.

Scientists advising the FDA had concluded the drug was safe and effective, but 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 publicly countermanded a determination by the FDA. It also 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 than the FDA on regulatory issues. 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 Nancy-Ann DeParle, Kathleen Sebelius and Margaret A. Hamburg have been the main players in this struggle. As leading defenders of the health reform law, Sebelius and DeParle, deeply loyal to the President, have been in the political trenches. 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 FDA.

Hamburg declined to respond to questions for this article and provided a written statement that stressed that the FDA will continue to work with our colleagues at the White House and across government to protect and promote the health of all Americans. DeParle declined to comment.

White House officials describe their disagreements with the FDA 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 White House Press Secretary Jay Carney.

The administration also views the FDA's hostility to its oversight as hopelessly naive, 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 FDA's budget and championing landmark legislation that strengthened the agency's authority to regulate food and tobacco. But they also express concern that the administration has been overly cautious, sitting on important regulatory policies regarding foods and medical devices to avoid giving Republicans fodder for attack.

Some analysts worry that the administration's increased engagement could erode the FDA's reputation for regulatory thoroughness and integrity. In a globalising world, where trust is a huge part of what American manufacturers have to sell, the politicisation of the FDA could hurt not only consumer protection but industry profits as well, said Daniel Carpenter, an FDA historian at Harvard University. If this trend continues, one could easily see major government purchasing programmes in Europe, India, China and elsewhere saying, We're not going to follow FDA recommendations anymore.'

The tensions between the White House and the FDA are also a window on 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 Centres for Disease Control and Prevention said. And in the end, it can't really be done.

Delegated power

When the FDA was considering in 1999 whether to approve the hugely controversial abortion drug RU-486, Jane E. Henney, its Commissioner at the time, went to a routine meeting with her boss, Donna E. Shalala, the Clinton administration's Health Secretary. Henney advised Shalala that the FDA would use its usual product approval process regarding RU-486, which would mean that neither 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, Shalala said, according to accounts from her and 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 Health Secretary the power to regulate food, drugs and other health products, but that authority was for decades delegated almost wholly to the FDA, which jealously guarded its independence.

Power shift

The George W. Bush White House began supervising the FDA more closely. Republicans were critical of government regulations, and the FDA issued more rules with greater influence over daily life than any other agency.

The Bush administration repeatedly stopped it 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. Bush's Health Department also demanded that it approve all FDA press releases. The Obama administration, it was felt, would restore the FDA's independence. A decision that had nothing to do with the FDA proved the turning point in its 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 U.S. 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.

That scared the bejesus out of everybody, a top FDA official said. The Obama administration became extremely risk averse, fearing further controversies might jeopardise the passage of health care reform, FDA and administration officials said.

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 favoured standardised rules over a hodgepodge of state and local ones.

The FDA's first draft of the guidelines approved by the Department of Health and Human Services and the White House stated that movie theatres, lunch wagons, trains and airlines would be included. A report about the proposal in The Wall Street Journal on August 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 FDA official said.

Beth Martino, the FDA's chief spokeswoman, was instructed to write a blog post reversing the agency's draft guidelines even before the comment period closed, and she did so on September 8. Consumer advocates were outraged. Movie theatre popcorn is such a nutritional disaster that people deserve to know what they're getting, said Margo Wootan, director of nutrition policy at the Centre for Science in the Public Interest. An administration official denied that the White House had worried about Beck and defended the decision. When was the last time you went to a movie theatre and you said, Man, I'm so excited to eat here?' the official asked.

Price factor

Then in February 2011, the FDA 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 officially approved one, the FDA 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 FDA 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 FDA 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 FDA to issue a press release stating that, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that make unapproved versions of 17P.

Cindy Mann, the Medicaid Director at the Centres for Medicare and Medicaid Services, sent a memorandum to State Medicaid programmes that they were free to continue buying the cheaper versions.

An administration official said the Health Department and the FDA worked together on the 17P issue and the White House was not involved. The notion that the statement or the action was somehow forced down the FDA's throat isn't accurate, the administration official said.

FDA 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 FDA official said.

Sunscreen controversy

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 FDA 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 ageing, while the administration insisted they could still be called sunscreens as long as they carried a label that said such lotions were ineffective. The FDA replied that people often fail to read labels and warnings.

An administration official said that as long as consumers were 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 that Sunstein supported, the FDA decided products with SPFs of 14 or lower could be called sunscreens but must carry warnings.

Asthma medicine ban

Some months later, the FDA 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 FDA had for years warned Amphastar, 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 underwrote an expensive lobbying campaign to stop the 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 FDA from removing Primatene from the market because they said the ban was a burdensome regulation.

Such lobbying is not unusual for the FDA. What was unusual, several top agency officials said, was the effort by Sunstein to persuade the FDA to give Primatene a reprieve. Usually, we can ignore all the lobbying stuff. We get it all the time, a top FDA official said. But when we get pressure from inside the administration, that's when it gets really tough.

Sunstein must approve new government rules. But in the case of Primatene, the law and rules were already in effect. The FDA did not need his agreement and resisted his entreaties, officials said.

Sunstein would not comment for this article. An administration official said Sunstein's brief use of Primatene many years ago had played no role in his views. 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.

In December, when Kathleen Sebelius overruled the FDA'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 lost effectiveness the longer women waited before taking it after unprotected sex, so the case for easier access was compelling, the FDA had concluded. The current requirement that those 16 years 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 FDA, resigned in 2005 to protest against the Bush administration's refusal to make emergency contraceptives available without a prescription.

In 2009, the White House invited Wood to attend a ceremony during which 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.

Wood said she felt that Obama broke that promise and feared future administrations would overrule the FDA 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.

2012 New York Times News Service