The US food and drug administration needs serious reform. Obama's choices to lead it aren't the right ones.
By Jeff Stier, Esq., Henry Miller
Posted: Sunday, March 15, 2009

EDITORIAL
Publication Date: March 15, 2009

This piece first appeared on March 15, 2009 in the UK's Guardian newspaper:

The one thing everyone in Washington seems to agree on these days is that the food and drug administration is in trouble and needs major "change". Yet the more important issue is whether, and how, the FDA will change under a new commissioner – because that has major implications for the health of both individuals and the nation's economy. The agency, which regulates products worth more than $1 trillion – or 25 cents of every US consumer dollar – has become a huge impediment to patients' getting the drugs they need. Reforming a demoralised and chaotic FDA will require leadership that manages competently, goes where the science leads, is untainted by ideology and is sufficiently strong to deflect congressional brickbats.

That's why the Obama administration's selections for the two top jobs at the FDA are especially disappointing. Although Dr Margaret Hamburg, the nominee for commissioner, boasts significant experience in government and is highly thought of in the public health community, her new deputy, Dr Joshua Sharfstein, is an inconceivably poor choice.

The selection is particularly bad given the expectation that Sharfstein will be entrusted with oversight of the most important sector of FDA-regulated products. Reportedly, the Obama administration will effectively split oversight responsibilities within the agency, with Hamburg responsible primarily for food and tobacco (if the agency gets control of it), and principal deputy commissioner Sharfstein overseeing the regulation of all pharmaceuticals (drugs, biologicals, medical devices and veterinary drugs). From the vantage point of industry and patients, this would make Sharfstein a far more influential figure than his nominal boss – but without requiring confirmation by the Senate.

Admittedly, the head of the FDA has long been one of the most difficult jobs to fill in US government. On most high-profile issues, the incumbent is subject to intense criticism from a number of quarters, and the position has never been a stepping stone to fame or fortune. The new leadership will face the added challenge of addressing the legacy of recent incumbents – who imposed excessive and expensive burdens on those trying to bring new medicines to consumers, pushed drug development costs into the stratosphere, damaged agency morale and permitted the drug approval process to become politicised.

The new FDA leadership must also confront a trend that has become popular – especially among members of Congress and the media – of vilifying drug companies, and even alleging that regulators have become too cosy with industry. In response, the FDA has battered the pharmaceutical industry with overly risk-averse, burdensome new policies, as well as erratic and dubious decisions on individual products. As a result, Sharfstein in his new job will need to establish credibility and rebuild trust with a variety of stakeholders – including drug companies and their investors, patient groups, consumer activists and members of Congress from both parties.

It's too bad, then, that Sharfstein has such a long history of hostility toward the pharmaceutical industry. While a medical student at Harvard, he led a campaign urging classmates to return textbooks donated by a pharmaceutical company. According to the university's newspaper, Sharfstein and his group alleged that the texts "are paid for by consumers in the form of higher drug prices. Accepting gifts from companies violates an ethical obligation to our future patients". They set up a drop-box, where, like a gun amnesty program, students were urged to return the books. (The project failed – apparently, most of Sharfstein's classmates were less radical than he.)

Of course, it wouldn't be fair to predict an official's future approach to issues based only on his youthful activism. But the "us versus them" view of the pharmaceutical industry that Sharfstein adopted at Harvard has stayed with him throughout his career. He went on to work as health policy advisor to Democratic congressman Henry Waxman of California, who personifies the divisive approach that castigates and persecutes innovative pharmaceutical companies. (Unsurprisingly, Waxman has been lobbying for Sharfstein's appointment to the FDA's top job.)

As the public health commissioner in Baltimore, Sharfstein engaged in typical functions of a city health commissioner, such as going after lead in candy. But he also (reasonably) advocated against marketing cold medicines to children under four, where there was little evidence of efficacy.

These are difficult times for both the drug industry and its regulators. Drug development costs are up while approvals are down. Leadership at the FDA will demand nuance and the ability to weigh benefits and risks – including the risks of excessive regulation. Federal regulators should not be collaborators with industry, to be sure, but they must cooperate with drug manufacturers in order to get new drugs to patients in a timely and cost-effective way.

Sharfstein has shown no willingness to do so, nor does he have any experience with the arcane and high-risk business of developing and regulating prescription drugs. He is far more likely to waste time and energy collaborating with activists who wish to end free drug samples to consumers. One wonders: As deputy commissioner, would Sharfstein allow FDA external advisory committee panels to benefit from the top experts in each specialty? Or would he consider them biased if they ever performed clinical trials or consulted for industry? And would he hold avowed anti-industry scientists to the same tough standards?

President Obama has pledged to "restore science to its rightful place". But that place is not where Sharfstein is to be found. Where the FDA and its constituents end up as a result remains to be seen.


Jeff Stier is an associate director of the American Council on Science and Health. Henry Miller is a physician and molecular biologist and a fellow at Stanford University's Hoover Institution. His most recent book is The Frankenfood Myth.