FDA Approval Report Contains Good News for Patients and Industry

By John Kamp, Executive Director, Coalition for Healthcare Communication —

Nov. 7, 2011 – Until the research labs and the FDA approval process deliver more medicines, neither patients nor industry can start singing “Happy Days Are Here Again.”

But, the report last week from the FDA Center for Drug Research and Evaluation does demonstrate substantial progress, at least for specialty drugs, orphan drugs and even a few larger-scale oncology medicines.

Indeed, despite rumors to the contrary, medical innovation is not dead. Thanks to continued research investment by industry and a clear commitment by the FDA to approve drugs while effectively managing risk, medicines for cancer and other increasingly difficult conditions are being approved and used to both extend the lives and improve the quality of life of patients.

The FDA’s report card for drug approvals in the past year looks pretty good. Although most of the approvals are for drugs with relatively small markets, each one denotes progress. The agency approved 35 innovative new drugs – the second-highest number of new drugs approved in a given year during this decade. Further, 24 of the 35 new drug approvals occurred in the United States “before any other country in the world and also before the European Union, continuing a trend of the United States leading the world in first approval of new medicines,” according to an FDA press release touting the results.

And, while industry and patient groups may not be ready for a ticker-tape parade, the FDA report credited the following for the increase in approved new drugs:

  • Expedited approval authorities;
  • Flexibility in clinical trial requirements; and
  • Resources collected under the Prescription Drug User Fee Act.

“Thirty-five major drug approvals in one year represents a very strong performance, both by industry and by the FDA, and we continue to use every resource possible to get new treatments to patients,” said Commissioner of Food and Drugs Margaret Hamburg, M.D. “We are committed to working with industry to promote the science and the innovation it takes to produce breakthrough treatments,” she stated.

Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President for Scientific and Regulatory Affairs Dr. David E. Wheadon expressed a similar sentiment, issuing the following statement regarding the FDA’s report: “The FDA’s report on new drug approvals – finding that 35 new molecular entities received FDA approval in fiscal year 2011 – demonstrates the shared commitment of biopharmaceutical research companies and the agency to medical progress and patient care.

“By approving these new medicines, FDA is helping to provide patients with access to new medicines that offer hope in meeting unmet medical needs.  Of course, the tremendous value of these advances – and FDA’s review and approval of them – underscores the importance of expedient approval of a clean Prescription Drug User Fee Act (PDUFA), which will help provide the resources needed to allow FDA to continue to serve, and enhance, its essential function.”

PhRMA’s Dr. Wheadon put his finger on it. Congress can pass a clean PDUFA bill that enables efficient scientific reviews using user fees. Or it can make it an “ugly Christmas tree,” as they call it on Capitol Hill, loading it up with so many ornaments that the whole thing falls over from the dead weight. Several nasty ornaments are being readied by “consumer groups,” including additional marketing and “conflict of interest” regulations. Members of Congress must reject these to enable both the innovation and communication that brings drugs to patients.

Most importantly, for patient’s sake, industry/government collaborations must be fostered. It is

confluence of interest that makes medical innovation progress. Let’s keep up the momentum.