After Heparin: - The Pew Charitable Trusts

PHARMACEUTICAL MANUFACTURING: GLOBALIZATION AND QUALITY MANAGEMENT
1.4.2 Manufacturing quality issues in the United States
Drug-quality problems are not restricted to emerging economies or to areas where oversight is weak.
The FDA has observed quality failures at domestic manufacturers in recent years, and the United States
has also experienced an upward trend in drug product recalls. The number of product recalls has consistently
risen since 2005, with a sharp increase in 2009 (see figure 11). Drug product recalls in 2009
represented a fourfold increase over recalls in 2008 (1,742 and 426, respectively). 285,* Of the 2009
recalls, 1,384 (nearly 80 percent) were for problems with manufacturing or testing methods. 286 This
increase in recalls may not reflect an increase in manufacturing quality problems, as multiple products
may be impacted by GMP violations at one plant. However, manufacturing issues have become a much
more prominent concern in the FDA’s warning letters to industry, with 34 cGMP warning letters sent to
drug companies in 2009, approximately double the total in 2008 (see figure 12). 287 The recent events
described below have, in many cases, been discovered because of FDA plant inspections, which occur
much more frequently in the United States than overseas (see section 2.1).
■ In 2010, Johnson & Johnson recalled more than 130 million bottles of children’s cough and cold
medicines 288 after an FDA inspection revealed 20 alleged cGMP violations, including failure to
conduct an adequate investigation of inactive ingredients that were contaminated with bacteria. 289
■ In April 2010, the FDA warned the Michigan-based L. Perrigo Co., which also manufactures
OTC cough and cold medications, for multiple cGMP violations, 290 including the discovery
ibuprofen tablets contaminated with metal shavings. 291 The FDA has reported cGMP and compliance
issues at Perrigo since 2005. 292 In 2006, that company recalled 384 lots of acetaminophen
tablets after the discovery of metal particles in some of the drugs. 293
■ In October 2010, GlaxoSmithKline (GSK) agreed to pay $750 million in a civil plea agreement
for distributing adulterated drugs that did not meet necessary levels of strength, purity or quality.
The United States contends that some of the drugs contained the wrong amount of active ingredient,
and some were possibly exposed to contamination by microorganisms. 294,†
■ In May 2010, Genzyme Corp. signed a consent decree with the FDA and agreed to pay $175
million after the agency discovered serious manufacturing quality issues at the company’s Allston,
Mass., plant. Alleged violations included drug contamination with metal, glass and rubber
particles, and viral contamination in manufacturing equipment. The consent decree holds
Genzyme to a strict schedule of improvements to bring its plant in line with FDA regulations. 295
* Includes 50 recalls for dietary supplements found to contain pharmaceutical active ingredients.
† The charges against GSK were brought under the False Claims Act—a law providing remedy for false claims made against the government, including
charges to Medicaid and Medicare for drugs. Most false claims cases in the pharmaceutical realm relate to the marketing of drugs for unapproved uses.
This was the first settlement of a case brought under the False Claims Act regarding pharmaceutical manufacturing quality.
After Heparin: PRotecting Consumers from the Risks of Substandard and Counterfeit Drugs 37