Manufacturers will be busy in the coming months dealing with continued scrutiny of safety signals, pressure to discover important new treatments, and resistance to high prices for medical products. This column will examine some of the leading policy issues on the table for 2008.
Implementing FDAAAThe legislative wrangling is over, and now the lawyers are in charge of deciphering what members of Congress really intended in many complex and contentious portions of the FDA Amendments Act (FDAAA). Considerable uncertainty remains about how and when manufacturers will have to file Risk Evaluation and Mitigation Strategies (REMS), especially for high-risk drugs already on the market. FDA must define a process for tracking and enforcing compliance with Phase IV study commitments. And new requirements for registering a greatly expanded range of clinical trials and trial results present a substantial challenge for FDA and the National Library of Medicine.
Woodcock is temporarily heading the Center for Drug Evaluation and Research (CDER), following the departure of former CDER director Steven Galson. She is thus responsible for issuing guidances, determining the need for revised regulations, and establishing the many policies FDAAA requires under tight timeframes.
A serious complication when Pharmaceutical Technology went to press last month was that FDA was not yet able to use the added revenues authorized under the Prescription Drug User Fee Act section of FDAAA. Although FDA could start collecting the higher fees, it cannot spend the money until Congress approves its 2008 appropriations bill, which has been delayed by partisan wrangling between Democrats and the Bush administration over all federal government expenditures. Because of these circumstances, efforts to modernize FDA's adverse-event reporting system and to expand access to outside safety information to fulfill new requirements may be slow to get off the ground, as required by FDAAA.
Slowing down for safety
While implementing new programs, FDA faces the challenge of demonstrating that it has not become gun-shy about approving new drugs for market. New drug approvals were down last year, including the number of new molecular entities (NMEs) coming to market. Manufacturers complain that the agency is issuing more "approvable" letters that demand additional trials and testing before final approval, and that many approvals carry narrower indications. Black-box warnings seem to be proliferating, as well as agency safety alerts and advisory committee reviews of safety issues for certain drugs and drug classes.
In just the last few months, for example, FDA has been examining safety issues related to asthma drugs, attention deficit hyperactivity disorder products, and cold remedies for children. The agency recently issued an alert that a smoking-cessation treatment may promote behavioral changes, and that an immunosuppressant drug carries added risks for pregnant women. The possibility that osteoporosis treatments may raise cardiac risks is under review.