NIH Advocates Should Be FDA Advocates Too

ADVOCACY

Upcoming Meetings

• June 9: Office of Management and Budget and Senate Agriculture Committee. On June 9th the Alliance is scheduled to meet with officials at the Office of Management and Budget and also with the staff of the Senate Agriculture Committee.

• Week of June 14: Michael Taylor, FDA Deputy Commissioner for Foods

• Week of June 28: Karen Midthun, Director of the Center for Biologics Evaluation and Research (CBER)/li>

ANALYSIS AND COMMENTARY

NIH-oriented patient and research advocacy groups were key to the founding of the Alliance for a Stronger FDA and make up a third of the Alliance’s board. Our membership from this stakeholder group has grown over the last couple of years as more organizations recognize that “the very best NIH, even well-funded” is still limited in its impact unless new therapies are approved by FDA.  An Alliance member asked us this week if we could send over a few talking points on the theme: NIH advocates need to be FDA advocates. Here is an edited version of what we provided.Billions of dollars are spent on biomedical research at NIH and academic health centers and by biopharmaceutical and medical device companies. While much remains to be done, there have been some great successes and a lot of progress. Patients, clinicians and researchers need to be leaders in advocating for increased funding of NIH.Through public and private funding, patient care has also come a long way as a result of advances in medical knowledge derived from research. The combination of centers of excellence and networks of community providers has advanced treatment to the point that most patients can expect to receive treatment based on the latest research and up-to-date protocols. Patients, clinicians and researchers have also been strong supporters of efforts to translate new knowledge into better care.In between the promise of research and the benefits of improved care … lies the US Food and Drug Administration, which must consider and approve all new medical therapies that involve drugs, biologics and devices.The patient and research advocacy community have a large stake in a strong, well-funded and effective FDA. Patients and family members want breakthroughs to move quickly to the clinic, so improved care is available sooner. They also want thorough reviews to assure that patients are not exposed needlessly to treatments that don’t work or are unsafe.To accomplish this, FDA needs to be strengthened as an institution to assure that there are more scientists, statisticians and clinicians at the agency to review applications for new treatments. Otherwise the fruits of research may never make their way to patient bedsides.Leading the charge for better FDA funding is the Alliance for a Stronger FDA, a broad coalition of consumers, patients and industry that has come together to advocate for more appropriated funds for the Agency. Increases in FDA’s budget would:

• allow the FDA to provide faster and safer approval of products that are saving lives and transforming health care;

• promote new drug technologies that will revolutionize pharmaceutical therapies

• ensure continued U.S. leadership in drug innovation;

• enhance the surveillance capability over new drugs once they reach the market; and

• further integrate emerging science into the regulatory process.

All patients benefit when FDA has more resources.

Note: This analysis and commentary is written by Steven Grossman, Deputy Executive Director of the Alliance.