"UNAUTHORIZED" WHOLESALER DISCLOSURE OF SUPPLY SOURCES
Executive Summary
"UNAUTHORIZED" WHOLESALER DISCLOSURE OF SUPPLY SOURCES to their customers is currently considered to be required under the Prescription Drug Marketing Act, FDA Associate Commissioner for Legislative Affairs Hugh Cannon said in an Aug. 9 letter to Sen. Heinz (R-Pa.). "At the present time," Cannon wrote, "the agency believes the intent of the law is to require an unauthorized distributor to disclose, in a statement to its customers, identifying information regarding all previous sales of a prescription drug product." FDA's tentative interpretation of the drug diversion law "is supported by both the House and the Senate reports on the legislation," the letter states. The agency has taken its position notwithstanding the fact that "there has been some concern that disclosure of identifying information of all previous sales to an unauthorized distributor's customers will eliminate competition in the wholesale pharmaceutical market." The agency is still considering the issue and may change its position in the future. Heinz was one of several Senate Finance Committee members to write FDA in opposition to mandatory disclosure of drug suppliers by secondary-source distributors to their customers ("The Pink Sheet" May 22, p. 4). The American Association of Pharmaceutical Distributors maintained in comments submitted last October that mandated disclosure "could eliminate hundreds of millions of dollars of legal, highly competitive sales" ("The Pink Sheet" Oct. 24, p. 15). The drug diversion act requires "unauthorized" distributors "to provide to each wholesale [customer] of such drugs a statement identifying each sale of the drug (including the date of the sale before the sale to)" the customer. The Senate Finance Committee report explains the provision in a way that apparently supports the FDA interpretation. "Unauthorized distributors will be required to certify in writing to drug wholesalers the source and place from which they obtained their drugs," the committee said. The report defines "unauthorized" distributors as those "who do not have an ongoing business relationship with a manufacturer to provide wholesale distribution of that manufacturer's products."
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
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 Skin Infections Guidance Spurs Debate On Endpoint Relevance
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
Shire Hopes To Sow Future Deals With $50M Venture Fund
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