Drug Recalls Way Up In 2009

In 2008, the U.S. Food and Drug Administration (FDA) reported that 426 <"http://www.yourlawyer.com/practice_areas/defective_drugs">prescription and over-the-counter drugs were recalled. In 2009, that number surged to 1,742, according to a report on NJ.com, which cited the Gold Sheet. The Gold Sheet is a trade publication analyzes FDA data.

Drug repackager Advantage Dose—which has since closed down—was linked to over 1,000 of 2009’s recalls, said NJ.com. But even taking Advantage Dose out of the analysis, recalls increased by a massive 50 percent last year. And, there is no slow down in sight, noted NJ.com.

From January to June of this year, 296 drugs have been recalled, said Bowman Cox, managing editor of the Gold Sheet, wrote NJ.com. “If we continue at this same rate, we could get 600 or more recalls by the end of the year,” Cox said. “That’s still a very high rate of recalls,” quoted NJ.com. “We’ve seen a trend where the last four years are among the top five for the most number of drug recalls since we began tallying recalls in 1988,” said Cox, quoted NJ.com “That’s a meaningful development,” added Cox.

Media frenzy surrounding some recalls, for example Tylenol and other Johnson & Johnson’s McNeil Consumer Healthcare products, have pointed to manufacturing issues, according to some experts, reported NJ.com. Also, according to NJ.com, two bills have been introduced this year seeking to mandate stricter industry regulations and broaden FDA authority to mandate recalls.

For instance, earlier this month, we wrote that on the same day that the FDA proposed changes to how medical device approval is fast tracked, new legislation was introduced to improve drug safety. Senator Michael Bennet introduced the legislation, which he said would significantly add to current FDA authority and increase the onus drug companies face for accountability for the drugs they sell, explained The Hill.

Senator Bennet explained that with drugs and drug components being manufactured overseas that, “For too long, the FDA has lacked the proper authority to adequately safeguard our drug supply,” quoted The Hill. “Americans need to be able to trust that the drugs in their medicine cabinets are safe, no matter where they’re made,” he added.

A poll just released by the Pew Prescription Project found that most Americans—89 percent—support Congressional action to increase drug safety in the United States, with 58 percent indicating that they “strongly support,” these actions, wrote The Hill.

As expected, the drug lobby feels additional consumer protections are unwarranted. Ken Johnson, a senior vice president of the Pharmaceutical Research and Manufacturers of America (PhRMA), a key lobbyist group for branded medications is among those who claim the proposal is not needed, wrote The Hill.

This entry was posted in Pharmaceuticals. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.