Generic Biologics Get a Boost
Creating a process at the Food and Drug Administration for approving generic biologic drugs, called follow-on biologics (FOBs), could lower biologics' cost, the Federal Trade Commission said. But the 12- to 14-year exclusivity period sought by biologics manufacturers is too long, according to the agency. FOBs wouldn't tread deep into innovative products' turf—those drugs would retain 70%-90% of their market shares and continue making substantial profits—according to the FTC. Rep. Henry A. Waxman (D-Calif.), who has introduced legislation to create a regulatory pathway for FOBs, praised the report. But the Biotechnology Industry Organization blasted it as “fundamentally flawed” and based on a “lack of true understanding of the necessary conditions to drive future biomedical breakthroughs.” The full FTC report is available at
www.ftc.gov/os/2009/06/P083901biologicsreport.pdf
NIH Targets Rare Diseases
The National Institutes of Health has created a pipeline for drugs to treat rare and neglected diseases. This spring, Congress provided $24 million for the program, which focuses on collaborations among NIH researchers in these areas. The initiative is supposed to go beyond the Orphan Drug Act by offering support for preclinical research and product development. NIH will seek private companies to carry out testing with patients. The program “will develop promising treatments for rare diseases to the point that they are sufficiently 'derisked' for pharmaceutical companies, disease-oriented foundations, or others to undertake the necessary clinical trials,” Dr. Alan E. Guttmacher, acting director of NIH's National Human Genome Research Institute, said in a statement. NIH estimates that there are more than 6,800 rare diseases but only about 200 of them have effective drug treatments.
Vermont Bans Most Pharma Gifts
Vermont Gov. Jim Douglas (R) has signed into law a bill that prohibits manufacturers of drugs, medical devices, and biologics from providing free gifts, including meals and travel, to physicians and other health care providers. The toughest of its kind in the nation, the legislation also requires disclosure of any allowed gifts or payments, regardless of their value. Under the stronger law, manufacturers can give physicians only gifts such as samples intended for patients, “reasonable quantities” of medical device evaluation or demonstration units, and copies of peer-reviewed articles. They still can provide scholarships or other support for medical students, residents, and fellows to attend educational events held by professional associations.
More Flu Preparation Needed
Federal and state governments need to do more to prepare for possible pandemic flu, the Government Accountability Office (GAO) said after reviewing the H1N1 flu outbreak. The office acknowledged pandemic planning throughout government but said that more efforts are needed to improve disease surveillance and detection, address issues of coordination between various governmental entities, and improve capacity for patient care in the event of a pandemic. The GAO warned that the H1N1 virus could return next fall or winter in a more virulent form.