FDA Officials Hail Increased Drug Approvals

The New York Times (11/4, A18, Harris, Subscription Publication) reports that officials at the Food and Drug Administration "on Thursday claimed credit for an increase in the approval of new drugs and argued that the results demonstrated the need for legislation to continue financing the current drug approval system." At a news conference FDA Commissioner Dr. Margaret Hamburg said, "I want to underscore that we approved a set of drugs that are truly medically important, and in fact did so in a way that made these drugs available to Americans before other places around the world." Noting that FDA officials have for years "said little about the declining number of new drug approvals," attributing them to a decline in quality applications, the Times adds that, with approvals on the upswing, Hamburg "is claiming some credit by saying that the agency has lowered some approval standards -- particularly for cancer drugs -- and speeded up many of its reviews."

CQ (11/4, Bunis, Subscription Publication) reports that drug makers "have complained in the past that the approval process takes too long and puts the US at a competitive disadvantage with other countries." The FDA report "says that the US 24 of the 35 drugs approved were approvals occurred in the United States before any other country in the world and also before the European Union." Among the successes highlighted in the report are approval of medicines for lung cancer and lymphoma that "are breakthroughs in personalized medicine," seven major improvements in cancer treatment and 10 for rare "orphan" diseases. Almost half the new approvals were viewed as significant therapeutic advances for heart attack, stroke and kidney transplant rejection, and two-thirds were completed in a single review cycle.

Bloomberg News (11/4, Edney) notes that the report of "particularly notable" new treatments includes Johnson & Johnson prostate cancer drug Zytiga, and Roche AG's Zelboraf melanoma drug. It also pointed to a new hepatitis C treatment, and Benlysta, the first new lupus therapy in 50 years, from Human Genome Sciences Inc.

According to Reuters (11/4, Yukhananov, Selyukh), the FDA report stresses how the user-fees it collects from drugmakers have helped shorten the agency's review times. Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, said that the higher number of approvals did not stem from the agency receiving significantly more applications, but from getting better-quality applications.

Regulators' Claims Precede Hill Fight Over User Fees. The Hill (11/4, Pecquet) "Healthwatch" blog notes that the FDA "touted a banner year for drug approvals as Congress prepares to renew industry user fees that fund the agency." It notes that the FDA, "like other federal agencies, faces looming cuts as Congress seeks to pare back a $1.3 trillion deficit," and that the industry user-fee funding drug approvals is scheduled to expire at the end of September 2012. While the agency "has reached agreement with the two main drug lobbies -- the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO) -- on a deal that would trade a $100 million increase in fees over five years for a more predictable drug approval process," Congressional approval would be needed.

The National Journal (11/4, Fox, Subscription Publication) reports that the new report "is the first time the FDA has specifically reported on how many new drugs it has approved. A spokeswoman said that the agency would also review new drug approvals at the end of each calendar year." It also notes criticism of the user-fee funding arrangement by Public Citizen, which says that since its passage in 1992, "there have been an unprecedented number of drugs approved and then withdrawn for safety reasons."