AIDS panel recommendations

The following summarizes the recommendations reached by the The National Task Force on AIDS Drug Development:

Market protection The Clinton administration should evaluate the potential impact of amendments to the Hatch-Waxman Patent Restoration Act designed to ensure that biotechnology and pharmaceutical products do not lose patent term due to delays in marketing approval from the FDA. - The administration should propose legislation providing a fixed period of extended market exclusivity for all treatments for HIV/AIDS. - The administration should propose legislation that provides a 50 percent R&D tax credit for all HIV/AIDS-related clinical research expenditures incurred prior to marketing approval. The same type of credit should apply for all HIV/AIDS-related clinical research expenditures incurred following accelerated approval, as required by the FDA, that examine new indications or formulations. Both credits should be made permanent and be allowed to be carried forward. - The administration should propose market exclusivity incentives for manufacturers that complete infant formulations, safety, pharmacokinetic and, as appropriate, efficacy studies of HIV and AIDS drugs.Regulatory - The FDA should continue to achieve "its excellent record of rapid initial review and approval of antiretroviral drugs, and ensure that it meets the same high performance standards for anti-infective drugs and biological products for treatment of HIV/AIDS and related conditions."...