Issa questions FDA over J&J plant, bill could offer fixes
House Oversight Chair Darrell Issa has been looking into the FDA’s action at a closed Johnson & Johnson medicine plant in Puerto Rico. Three months after the Justice Department took ownership of three troubled J&J plants through a consent decree, Issa is concerned that regulators and the company aren’t working quickly enough to fix the deep quality problems there.
According to Bloomberg, Issa complained that regulators have not reviewed corrective action plans for the plant since the division was taken over in March, and have not visited the site since September.
Remember, that’s before a pretty bruising hearing in late September 2010 at which J&J had few answers about why it carried out a “phantom recall” to pull faulty Motrin from shelves, and the FDA said that it found quality problems in every one of J&J’s plants.
While it’s good that Issa’s subcommittee is keeping an eye on the FDA and the progress of the J&J case, the Energy and Commerce Committee has already identified some of the root problems and drawn up smart, comprehensive solutions—not just to the J&J case, but to the system failures behind some of the company’s problems.
The Drug Safety Enhancement Act (HR 1483), introduced in April, would answer some of Issa’s question by boosting mandatory inspections, and giving the FDA better enforcement tools in the form of recall and subpoena authority.
Issa is right to question the J&J aftermath and be dismayed at the larger problems in our drug safety system. He and his committee members should recognize the DSEA as an important step toward fixing those problems, and make sure this bill has the support it needs to move in Congress.
Read more on the bill at the blog, and a summary of HR 1483 here (pdf).
-Kate Petersen, PostScript blogger