Healthy Skepticism Library item: 14956

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Publication type: news

Taylor L.
FDA “must no longer regard drug trial data as proprietary,” Obama is told
PharmaTimes 2009 Jan 21
http://www.pharmatimes.com/WorldNews/article.aspx?id=15156&src=EWorldNews

Full text:

While the US Food and Drug Administration (FDA) is regarded by many as a failed agency, the Obama Administration has the opportunity to reinvigorate it, but only through efforts to protect it from undue influence and promoting transparency, says a controversial front-runner to be the new FDA Commissioner.

To insulate the agency from political influence, the next commissioner should serve a fixed six-year term, according to Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic in Ohio. He also calls for a re-evaluation of the system by which drugmakers fund a large portion of the agency’s budget through the Prescription Drug User fee Act (PDUFA).

Dr Nissen’s recommendations appear in a feature entitled “Your Inbox, Mr President,” in which six leading voices tell readers of the current issue of Nature what President Obama needs to do to move beyond the Bush legacy.

Most controversially, Dr Nissen’s proposals call for the FDA to cease regarding clinical trial data as proprietary, and for it to provide access to all available information on safety and efficacy, whether gathered during approval for drugs or post-approval surveillance. “Secrecy is antithetical to both science and good government, but much of what the FDA knows about drugs, it never publicly discloses,” he writes.

The FDA also needs to improve harmonization between its Office of Surveillance and Epidemiology (OSE), which monitors post-marketing safety, and its Office of New Drugs (OND), which is responsible for post-marketing regulatory decisions, he adds.

Dr Nissen’s recommendations also call for the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) to have the right to restrict direct-to-consumer (DTC) advertising during the first two years a drug is marketed and to preview advertising to ensure it is not misleading. “An FDA policy introduced in 2008 unwisely allows off-label promotion of drugs and devices through distribution of article reprints, an approach that may encourage unsafe use for unapproved indications and discourage appropriate clinical trials to establish new indications,” he says.

The newly-elected chairman of the House Energy and Commerce Committee, Representative Henry Waxman, has already suggested that an early task for the new Congress could well be to revisit moves to allow the FDA to ban DTC ads for new products during their first few years on the market, if the agency considers this necessary to protect the public health. Legislation to give the agency such powers was introduced in Congress in 2007, but failed to progress.

In addition, Dr Nissen says that the approaches used by the FDA to approve drugs need attention, as they are often based on placebo-controlled clinical trials even though appropriate use of therapies requires understanding comparative effectiveness. Stronger enforcement capabilities are required throughout the agency, and the FDA must increase its overseas inspections and hold foreign government accountable for setting regulatory and safety standards for local manufacturing, he adds.

He concludes that, while the agency regulates $1 trillion-worth of food, drugs, cosmetics and medical devices, it does so with a budget of $2.3 billion, a quarter of that of the Centers for Disease Control and Prevention (CDC), which has a significantly more limited mission. “Congress must re-evaluate priorities and recognize that ensuring the safety of food and drugs is a crucial national priority,” he writes.

- Dr Nissen is currently regarded – with Baltimore Health Commissioner Joshua Sharfstein, who has been conducting an assessment of the FDA for the Obama transitional team – to be joint favourite to take over the helm at the FDA following the departure of Andrew von Eschenbach. However, both are long-term critics of the industry, and in a Pharmalot/CNBC poll of drugmakers, 75% said they were opposed to Dr Nissen being appointed to the post.

The link to the Nature article is http://www.nature.com/nature/journal/v457/n7227/full/457258a.html