Drug recalls, shortages suggest FDA needs greater authority for manufacturer compliance


A number of high-profile drug and biotech manufacturing breakdowns in recent months is raising questions about industry investment in, and commitment to, modern production systems able to meet FDA standards.

Key Points

A number of high-profile drug and biotech manufacturing breakdowns in recent months is raising questions about industry investment in, and commitment to, modern production systems able to meet FDA standards. For the past decade, FDA has campaigned for a more efficient, risk-based approach to monitoring biopharma manufacturing activities that encourages consistent production of high-quality products.

Yet, the massive recall in April of children's cold medicines produced by the McNeil unit of Johnson & Johnson (J&J) reflects repeated failures by the company in meeting regulatory requirements. McNeil has also recalled multiple lots of Tylenol, Motrin, and Benadryl produced at a plant in Puerto Rico-the latest announcement last month-actions that are beginning to affect consumer access to widely used over-the-counter medicines.

Genzyme Corp. continues its struggle to restore production capacity after contamination problems prompted closure of its Allston, Mass.-facility, a situation that has forced patients with rare disorders to do without vital therapies. And several vaccine makers are working hard to eliminate extraneous viruses from cell banks and to correct manufacturing issues identified by FDA inspectors. These and other situations raise questions about whether FDA has the authority it needs to forcefully regulate drug and biotech manufacturers, and whether companies are cutting corners on maintaining the quality systems needed to comply fully with standards for good manufacturing practices (GMPs).

Although some members of Congress initially chastised 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. 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 compliance with quality standards.

The J&J recall was voluntary because, under current policy, it's a very long and difficult process for 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 Committee indicated support for strengthening FDA's powers.

Sharfstein said that he wanted to "send the message" to manufacturers that FDA is significantly strengthening its oversight and criminal enforcement of manufacturing activities. In a seminal speech last August (2009), FDA Commissioner Margaret Hamburg emphasized the importance of industry adherence to regulations. Hamburg outlined initiatives to accelerate correction of manufacturing deficiencies identified during plant inspections and to streamline the process for issuing warning letters to those companies that fail to address violations expeditiously. That policy appears to be taking root, as FDA has stepped up the volume and timeliness of warning letters and has taken over action to compel industry compliance.

Deborah Autor, director of compliance at the Center for Drug Evaluation and Research (CDER), acknowledged at the May hearing that FDA's criminal investigative unit is examining whether there is potential criminal liability for McNeil's "phantom" recall of Motrin products in 2008 and for the company's slow response to FDA inspection citations.

There's also more talk of FDA injunctions and consent orders, and the pharma legal community is watching closely to see if the feds bring charges against J&J and McNeil executives for not doing more personally to prevent company violations of food and drug laws. Under FDA's "responsible corporate officer" doctrine, corporate executives who knowingly fail to prevent violative behavior could face stiff fines and even prison terms.

And while the McNeil investigation continues, Chairman Edolphus Towns (D, New York), of the House Committee, introduced H.R. 5740 in mid-July to amend the Federal Food, Drug, and Cosmetic Act. If enacted, the legislation would permit FDA to order the recall of an adulterated or misbranded drug. In a recent letter to Chairman Towns, the Academy of Managed Care Pharmacy (AMCP) expressed its support of this legislation "to increase the FDA's scope of authority in removing dangerous drugs from the market." The AMCP leadership is willing to work with Rep. Towns to "ensure patient's safety from harmful drugs."

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