Ruling Limits Medicare’s Ability to Set Drug Prices

FDA Misses Drug Decision Deadlines

The bargain embedded in the Prescription Drug User Fee Act is that pharmaceutical manufacturers agree to hefty filing fees when they submit a marketing application to the FDA in return for a quick decision—in general, within 10 months for routine applications and within 6 months for applications for drugs that have the potential to be major breakthroughs. However, this year, the FDA has not lived up to its part of that bargain.

A compilation by analyst Corey Davis of Natixis Bleichroeder Research identified 15 drug applications for which the deadline has passed without an FDA decision. On the list are prasugrel, a blood thinner developed by Lilly and Daiichi Sankyo; algoliptin, a diabetes drug from Takeda; and asenapine, a schizophrenia drug from Schering-Plough. In fact, the number of drugs on the list understates the number of delayed decisions because it excludes applications for which the agency has formally extended review times.

The problem is simply one of inadequate staffing. “There have been dramatic increases in workload that have not kept pace with increases in staffing,” explained John K. Jenkins, MD, director of the FDA’s Office of New Drugs.

Health Plans’ Class-Action Vioxx Suit Denied

With the Vioxx settlement administrator ready to begin making interim payments to persons who submitted claims for myocardial infarctions or strokes related to using the analgesic, employer-sponsored health plans that paid the medical costs of treating those persons argue that they, too, should be reimbursed. However, the US District Court of the Eastern District of Louisiana, which is handling the Vioxx claim cases, has ruled that if the plans want to make such claims, they must do so individually. The court rejected the plans’ attempt to have their claims heard in 2 large class-action suits.

The decision on the class-action application (In re: Vioxx Products Liability Litigation [MDL1657]) found that it would not be appropriate to handle all the claims together because each plan had different provisions covering reimbursement for medical services as well as different language spelling out its rights to recover payments that enrollees receive from other sources. Moreover, the ruling noted that the petitioners “cannot determine how many plans—or even which plans—they might potentially represent because they do not know who is participating in the settlement.”