DRUG DIVERSION BILL EMERGENCY SCHEDULING EXEMPTION
DRUG DIVERSION BILL EMERGENCY SCHEDULING EXEMPTION should be specifically granted to investigational drugs, PMA urged in recent comments submitted to House Health Subcmte. Chairman Waxman (D-Calif.). Commenting on the proposed provision giving the Justice Dept.'s Drug Enforcement Administration emergency drug scheduling authority, PMA said that an amendment should be added to "explicitly prohibit the emergency scheduling of pharmaceutical products having accepted medical use in the U.S. or which are being investigated to establish that use." The bill was introduced by House Judiciary Courts Subcmte. Chairman Hughes (D-NJ). Although the bill was amended by the House Judiciary's Courts Subcmte. in April to limit emergency scheduling authority to only those substances with "no currently acceptable medical use," PMA contended that the provision could be interpreted to allow emergency scheduling of investigational drugs. The assn. asserted that the bill "could permit the attorney general to temporarily schedule a compound which is the subject of an investigational new drug exemption (IND) because, technically, many IND drugs have no currently accepted medical value since they have not yet been approved by FDA for marketing." PMA submitted the comments following a July 31 hearing by the House Health & Environment Subcmte.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth