An FDA conundrum: speedier approval but slower – if not nonexistent – recall notifications

The U.S. Senate recently agreed to pass the Food and Drug Administration’s user fee legislation to speed the process of drug and device approvals and give the FDA more power in regulating foreign drug facilities. Under the new policy, brand name drug manufacturers will pay a 6 percent increase in fees, or $4.1 billion, to fund the FDA’s review program. Additionally, generic drug makers will pay $1.56 billion, medical device makers will pay $609 million, and generic complex drug makers will pay $128 million.

According to Bloomberg News, the FDA hopes to increase the availability of treatments for life-threatening conditions, to mitigate drug shortages, and to enhance safety monitoring of devices.

In the past, many device manufacturers underwent unexpected recalls after being approved under the FDA’s 510 (k) program, which eliminates the need for pre-market testing if a similar product is already being marketed. Now, companies can schedule additional meetings with the FDA throughout the review process in order to deal with concerns. The new program will also help drug makers plan clinical development programs.

"FDA's current drug-safety authorities are decades old and were never intended to address today's global market," said Deborah M. Autor, the agency's deputy commissioner for global regulatory operations.

On Monday, Reuters Health reported on a study that suggested the FDA also needs to do a better job of informing healthcare professionals and the public about recalls.

The study looked at 1,700 dangerous drug recalls that occurred last year, 91 of which were considered Class 1, the most serious type. Out of those recalls, the FDA allegedly only reported 55. The study likewise purports that the FDA’s MedWatch Program, a safety alert system, failed to report one-fifth of last year’s drug recalls last year. Failing to quickly issue safety alerts may pose a serious threat to a patient’s health as pharmacists continue to fill prescriptions for recalled medication.

“It’s unclear why it shouldn’t be 100 percent of the time they’re notifying people on both systems,” said Dr. Lisa Schwartz, a co-director at the Center for Medicine and Media.

A number of suggestions were made regarding how the FDA could improve their alert system, including implementing computerized systems. How do you think the FDA should rectify the problem?