Unshackle the FDA From Rules That Kill Innovation

The Obama Administration often proclaims that it works overtime to strengthen the competitive position of U.S. industry. If it’s sincere about this claim, it should be working to lower the time and cost that it takes pharmaceutical companies to bring new medicines to market, estimated to be over a decade at a cost of $1.3 billion per drug.

In addition to the endless regulatory hoops mandated by the FDA for marketing approvals, a significant, and wholly unnecessary, part of this protracted slow-down stems from sharp limits on conflict of interest waivers for the agency’s vital advisory committees that help the FDA review new medicines, which Congress imposed on the agency, with excessive zeal, in 2007.

Rather than coming from industry, complaints about onerous conflict-of-interest rules have come primarily from patients groups representing the users and consumers of pharmaceutical products, for whom new drugs and devices often spell the difference between life and death. On October 26, 2011, dozens of patient groups signed an urgent letter to Senators Tom Harkin and Michael Enzi, Chairman and Ranking Member of the Senate Committee on Health, Education, Labor and Pensions, pleading for Congress to rein in the draconian conflict rules specific to the FDA.

None of these distressed groups has ever questioned the abstract proposition that conflicts of interest need some regulation. No one tolerates, let alone champions, letting the manufacturer of a new drug or device place its scientists on the FDA Advisory Committees charged with vetting that product for safety and effectiveness.

These patient groups do, however, object vehemently to the current rules that virtually block any person with any financial connection sitting on any of FDA’s vital advisory committees. This prohibition has not only left about 20 percent of the FDA’s many committee positions vacant but also led to a pool of “experts” less qualified than those disqualified, by virtue of the simple fact that they are so pre-eminent in their fields that industry seeks out their advice and services.

In February, the same coalition of patients’ groups took its plea to a House hearing on the five-year reauthorization of the Prescription Drug User Fee Act (PDUFA), which lets drug companies pay fees to obtain more rapid FDA review of their new drug applications. At that hearing, Diane Dorman testified on behalf of the National Organization for Rare Disorders that additional conflict of interest rules imposed on the FDA “have resulted in a system that is out of balance to the point that conflict avoidance is the primary driver of who serves on the Advisory Committees, regardless of the extent of the conflict, the uniqueness of their expertise, or the government’s need for their services.”

Quite simply, the current FDA conflict of interest rules regard doctors and scientists with any financial connections with drug and device manufacturers as corrupt shills, who should be banished from its sacred precincts. Yet it takes an all-too-tolerant position to such “pure” advisors like Sidney Wolfe, from Public Citizen, who has served on the FDA’s Drug Safety and Risk Management Advisory Committee since 2008, despite being an avowed enemy of the industry and a close ally to plaintiff’s lawyers who launch multibillion dollar class action suits against drug companies – and who contribute generously to Public Citizen’s coffers.

In practice, no company can properly develop new medicines or their application for FDA approval without the assistance of leading medical professionals, who double as consultants. Indeed any company that did not hire these people would be remiss in their duties both to shareholders and to the patients they hope to serve.

Of course it would be unwise to have only industry consultants on committees. But all sorts of hidden biases can appear if these experts are systematically excluded from the process.

Any conflict of interest rule must, first and foremost, preserve the FDA’s broad access to a large pool of the most qualified scientists. Disqualification should be done on a case by case basis, upon proof of specific concerns, not by broad decrees.

Congress should thus reform the FDA’s conflict-of-interest regime, heeding the case of the patients’ groups testifying before them – who know that knowledge foregone at the FDA translates into cures delayed and lives lost.

This piece originally appeared in Forbes

This piece originally appeared in Forbes