DRUG DIVERSION BILL PASSES SENATE MARCH 31
DRUG DIVERSION BILL PASSES SENATE MARCH 31 by voice vote. The Senate adopted the House measure (HR 1207) 11 months after referral from the House. The bill was passed by the House on May 4 and by the Senate Finance Committee on Dec. 11. The bill permits nonprofit institutions to return recalled pharmaceuticals to their suppliers, under a clarification contained in the Senate Finance Committee's report, printed March 18. The report explains that the bill's prohibition against "resales and trades by hospitals and other health care entities of pharmaceuticals . . . does not include the withdrawal from the market for credit or exchange of any drugs in the event of a recall by a manufacturer, where the manufacturer has notified the secretary of HHS of the recall." The report also specifies that wholesaler reporting requirements apply to unauthorized distributors only. Section six of the legislation "is designed to restore accountability to the wholesale sector of the pharmaceutical market and to regulate the wholesale distribution of prescription drug products," the report states. A requirement in Section 6 "that distributors must inform their wholesale customers of all previous sales of the product applies only to wholesale distributors who are not authorized distributors for that product." the report states. Authorized distributors "are exempt from this requirement." The report defines "unauthorized distributors" as "those distributors who do not have an ongoing business relationship with a manufacturer to provide wholesale distribution of that manufacturer's products." The report notes that "unauthorized distributors will be required to certify in writing to drug wholesalers the source and place from which they obtained their new drugs." The bill will require manufacturers "to maintain for public review a current list of all authorized distributors of record."
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