The prospect of even more high-cost specialty drugs has spurred initiatives to make drug development and clinical research
more efficient. There's interest in more public-private collaboration on new research tools and faster identification of potentially
effective compounds. Many of the recently negotiated billion-dollar corporate acquisitions and asset exchanges aim to strengthen
drug development pipelines by shifting a company's focus to treatment areas where they have greater expertise. That strategy
may be effective, as seen in warnings from payers that pharma research consolidation will reduce market competition.
Congress weighs innovation
FDA has adopted multiple strategies to speed drug development and review. The breakthrough drug designation is a "game changer"
for addressing serious, life threatening conditions, commented Janet Woodcock, director of the Center for Drug Evaluation
and Research (CDER), at the annual meeting of the Food and Drug Law Institute in April. CDER received 144 requests for breakthrough
designation through April 4, granted 40 and denied 70, Woodcock reported, noting that the requests are not just for cancer
drugs, but also for antivirals and other conditions. Last year, nearly half of all new molecular entities approved by FDA
took advantage of some expedited review pathway, and several were approved in less than six months.
A related idea, designed to minimize the impact of new medical technologies on rising health care expenditures, is to extend
FDA mechanisms for expediting approvals to drugs also likely to cut costs. A recent Rand Corp. study on "Redirecting Innovation
in U.S. Health Care" further proposes more coordination between FDA approvals and Medicare coverage decisions, which again
would favor money-saving technologies. FDA and Medicare consideration of cost issues in regulatory and coverage decisions
would require legislation, as well as methods for determining how and when a new product truly has economic benefits.
These discussions may lead to adoption of specific Congressional proposals, possibly through legislation to renew prescription
drug user fees for 2017. There are bills before Congress to expand incentives for developing new antibiotics to address drug-resistant
infectious diseases, and growing concern on Capitol Hill about rampant abuse of prescription painkillers and opioids. These
issues may gain impetus as negotiations between FDA and industry on PDUFA VI move forward in the coming year.
Jill Wechsler is Pharm Exec's Washington correspondent. She can be reached at firstname.lastname@example.org