PAR SUPPLYING INFORMATION TO HOUSE OVERSIGHT SUBCOMMITTEE
Executive Summary
PAR SUPPLYING INFORMATION TO HOUSE OVERSIGHT SUBCOMMITTEE as part of Chairman Dingell's (D-Mich.) investigation into FDA generic division approvals. On July 15, Par confirmed that it had received a subpoena and will provide documents relating to meetings and conversations with FDA. The company says it will provide the material to Capitol Hill within two weeks. Par is the first company to publicly disclose that it has been contacted by the subcommittee. Responding to a sharp drop in the price of Par stock on July 14, the company said it is "one of a number" of firms that has been asked to provide documents in connection with the investigation. The Dingell subcommittee said that a "number of subpoenas" would be served on the industry. At least one company reports not receiving an inquiry as of July 15. The American Home Products' affiliate, Quantum Pharmics, says that it has not received a subpoena. American Therapeutics, which received the first approval for a generic version of Maxzide, declines to answer inquiries about the Capitol Hill investigation. The request for information from Par probably reflects the company's success in receiving ANDA approvals. In 1987, Par got ANDA approvals for 29 chemical entities.
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