Representative Rose DeLauro (D-CT), chair of the House Agriculture, Rural Development, Food and Drug Administration Appropriations Subcommittee, which oversees funding of the Food and Drug Administration, held an oversight hearing yesterday, “Improving the Drug Safety System at FDA.”

She made some strong and insightful comments in her opening statement at the hearing, which we excerpt below:

  • A little over 100 years ago, Congress passed the Pure Food and Drug Act. With President Theodore Roosevelt, Congress passed this landmark legislation to protect the American people from adulterated and sham drugs and unsanitary and dangerous foods. Reading the newspapers today, with daily stories about unsafe food and unsafe prescription drugs, it is easy to wonder if we have gone back in time to 1906.
  • Cases like this [the recent discovery of serious adverse reactions to a batch of the blood-thinner Heparin] or controversies surrounding Avandia, Vioxx, Trasylol and beyond — are embarrassing, but more than that they offer a window into the FDA’s myriad failures under the Bush administration. Its work motivated by ideology, compounded by incompetence, and negligence, and a lack of regard for the health and safety of the American public.
  • To restore the agency’s gold standard mission and ensure the fundamental safety of the drugs it regulates, I am guided by four principles:
    • First we must increase funding to support the FDA’s mission.
    • Second, we must improve the management of the agency and hold it accountable.
    • Third, we must push back against the influence of Big Pharma over the agency.
    • Finally, and perhaps most importantly, we must let the scientists do their work, guided by science and not political interference.
  • The FDA has been starved for resources under seven years of the Bush Administration. FDA managers point to a lack of resources as the reason for not carrying out their appointed duties. The administration is taking the bargain basement approach then using it an excuse for its poor performance…
  • But increased funding is only part of the challenge. Funds alone cannot fix an agency that routinely fails at its most basic responsibilities: keeping track of clinical trials, preventing conflicts of interest, following up on critical investigations. Sixty-five percent of post-market studies on new medications have not yet begun. This startling fact makes it clear what a long way we have to go.
  • Yet, in recent years, surveys consistently show that FDA scientists overwhelmingly complain about interference from top level FDA appointees on behalf of corporate and political interests. They feel that factors other than good science play a role in important FDA decisions. And that may be why too many good scientists continue to leave the agency at a time when we should trying to attract them and support their work.
  • We can no longer accept federal agencies tasked to protect the public health that seem only interested in protecting business from embarrassment or cost.