Manufacturing Compliance in the Spotlight - Plant closures, product recalls prompt FDA re-evaluation of GMP enforcement efforts. - BioPharm International

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Manufacturing Compliance in the Spotlight
Plant closures, product recalls prompt FDA re-evaluation of GMP enforcement efforts.


BioPharm International
Volume 23, Issue 8

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Although some members of Congress initially chastised the FDA for failing to keep McNeil's adulterated children's medications off the market, the agency came out looking pretty tough from the May hearing. The FDA was able to document a history of regulatory violations, failed inspections, and product recalls going back several years, along with multiple efforts by the agency to compel McNeil to comply with quality standards. Sharfstein cited frequent inspections and numerous warning letters, plus a meeting with corporate executives when those efforts failed to produce results.

Sharfstein also made the case for stronger FDA regulatory and recall authority. The J&J recall was voluntary because, under current policy, it's very long and difficult for the FDA to compel a company to pull products off the market. Even though most manufacturers comply with FDA recall requests, there often is a lag between when the company becomes aware of adverse events and quality problems, and when that information reaches the regulators. Several members of the House Oversight Committee indicated support for strengthening the FDA's powers, as did Rep. Rosa DeLauro (D-CT), chair of the House Appropriations subcommittee that oversees the FDA's annual budget. DeLauro sent a letter to Commissioner Hamburg complaining of McNeil's "reckless behavior" in disregarding GMPs at its facilities and suggested that the FDA might benefit from added authority to recall drugs, to require company monitoring of consumer complaints, and from more resources to conduct more frequent inspections.

The need for multiple inspections of J&J plants over the last few years also has raised the issue of whether manufacturers that require repeat site audits should pay additional fees for the extra services. Reinspection user fees have been on the FDA's wish list for several years as a way to boost revenue from those firms that create more work for agency inspectors. Some policymakers have proposed that the FDA collect fees for all field inspections, as done in Europe and many other countries. That's not likely to happen, but asking violative companies to pay more for reinspections and re-reviews may gain support.

Another outcome may be new rules from the FDA requiring more extensive pharmaceutical company monitoring of suppliers and contract manufacturers. The FDA holds the marketer of a finished drug responsible for ensuring that outside contractors comply with GMPs, but much of that oversight currently involves review of data and reports on quality control systems and product attributes. Now the agency is considering requiring biopharmaceutical companies to conduct on-site audits to ensure that contractors comply with rules and standards.

There's more talk of FDA injunctions and consent orders in the wake of examining a number of legal issues as part of the process for investigating McNeil's actions. The pharmaceutical legal community is watching closely to see if the FDA seeks charges against J&J and McNeil executives for not doing more personally to prevent company violations of food and drug laws under the FDA's "responsible corporate officer" doctrine; that could involve individual misdemeanor charges, which can carry stiff fines and even prison terms.

Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634,


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