Full article reprinted from "The Tan Sheet" -September 30, 2008
Find out why House Energy and Commerce Committee Chairman John Dingell likely will strengthen FDA mandates proposed in his evolving global drug safety bill in light of the agency's import alert for Ranbaxy products, including an OTC drug.
Full article reprinted from "The Tan Sheet" -September 30, 2008
House Energy and Commerce Committee Chairman John Dingell likely will strengthen FDA mandates proposed in his evolving global drug safety bill in light of the agency's import alert for Ranbaxy products, including an OTC drug.
In particular, Dingell is considering adding a new provision to his legislation to mandate that FDA conduct pre-approval inspections for 100 percent of abbreviated new drug applications from generic firms.
The Michigan Democrat has circulated a number of revised draft bills to expand upon his earlier legislation, H.R. 3610.
However, committee aides said global drug safety legislation is not likely to pass this year and Dingell is expected to introduce an updated bill when the 111th Congress convenes next year.
On Sept. 16, FDA issued two warning letters to Ranbaxy citing violations of good manufacturing practices at two plants in India. The letters address deficiencies in Ranbaxy's Dewas facility and its Paonta Sahib plant, which received a warning letter in 2006.
The agency also announced import restrictions on 26 finished drug products - including the bioequivalent of OTC Claritin Reditabs (loratadine) - and seven active pharmaceutical ingredients manufactured at those plants; two days later FDA added seven more finished products that had been omitted.
FDA conducted pre-approval inspections for 17 percent of Ranbaxy's ANDAs approved since 2005, Dingell said after the FDA action. Current law does not mandate a specific inspection schedule for generic drug products, which also are not covered by user fees.
The agency adopted a policy of 100 percent inspections after the generic drug issues in the 1980s, but the commitment dwindled as staffing and budgetary constraints rose over time, committee aides said.
Background staff testimony prepared for an April Oversight and Investigations Subcommittee hearing on imports of contaminated heparin noted FDA in 2005 adopted an eight-point set of criteria to prioritize pre-approval inspections. But it pointed out the criteria do not include plant location, manufacturing complexity or final product sensitivity, which were issues in the heparin situation.
The Generics Pharmaceutical Association Sept. 18 said it supports stronger foreign inspections as well as Dingell's legislative efforts.
FDA's import alert is a double-edged sword - on one side, the agency is "sending a clear signal that drug products intended for use by American consumers must meet our standards of safety and quality," Center for Drug Evaluation and Research Director Janet Woodcock said in a Sept. 16 release.
On the other side, each action in this area may serve equally to revive concerns about product safety, just as the previous incident starts to fade from the spotlight.
The Ranbaxy alert comes after Iceland-based Actavis' U.S. division, Actavis Totowa, in August said it recalled 65 Rx products manufactured at its New Jersey plant following an inspection that "revealed operations which did not meet" FDA's or the firm's GMP standards.
These and similar events could fuel congressional efforts toward tighter oversight of pharmaceutical production.
Dingell could find more fodder in a review of requested FDA documents that outline the decision-making steps that led to the import alert. And already there is evidence Dingell will use Ranbaxy as a rationale for action in other areas.
In July, the Commerce Committee began investigating allegations of fraud related to Ranbaxy manufacturing, prompted by a Justice Department investigation of the firm's manufacturing and product development practices. DOJ looked particularly at whether Ranbaxy and independent consulting firm Parexel fabricated bioequivalence and stability data in its ANDAs.
On Sept. 19, the committee expanded its inquiry, including asking Secretary of State Condoleezza Rice for documents relating to the safety and effectiveness of drugs manufactured by Ranbaxy for a program that provides AIDS drugs in developing countries.
- Becky Jungbauer
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