Wednesday, May 25, 2011

Congress "Deeply Troubled" With FDA/J&J

Bloomberg has;

J&J Puerto Rico Plant Has Deeply Troubling Lack Of Oversight

By Catherine Larkin - May 20, 2011 3:05 PM ET

"Johnson & Johnson (JNJ)’s plans to clean up a Puerto Rico factory haven’t been checked by U.S. regulators in what a Republican chairman of a House committee called a “deeply troubling” lack of oversight.

Food and Drug Administration officials haven’t visited the San Juan plant operated by J&J’s McNeil Consumer Healthcare unit since September, Representative Darrell Issa said today in a letter to Margaret Hamburg, the agency’s commissioner. Regulators stationed in Puerto Rico also told Issa that they haven’t reviewed corrective actions taken by McNeil as part of a consent decree the division signed with the FDA in March.

McNeil has pulled more than 40 brands of over-the-counter medicines since April 2010 because of contamination, musty odors, incorrect labeling and insufficiencies in manufacturing. The House Oversight committee that Issa chairs urged the FDA to follow up hearings held last year about manufacturing deficiencies at McNeil’s plants in Puerto Rico and Pennsylvania. Officials there say they don’t have enough resources, Issa said.

“I find this excuse deeply troubling and inconsistent with the resources made available to the FDA in the legal consent decree,” Issa, of California, wrote in his letter. This raises “several questions about the mismanagement of safety concerns at FDA’s San Juan office and the direction of the FDA’s oversight efforts in Puerto Rico.”

The FDA doesn’t comment publicly about letters from Congress as a matter of policy, Shelly Burgess, an agency spokeswoman, said today in an e-mail. The FDA will reply directly to Issa, she said."

Thank You Bloomberg & Ms Larkin

And this is Worse even than it appears Why?

Because even With Congressman Issa's putting the FDA on Notice that the situation is Deeply Troubling, the FDA has Already Flunked J&J on 48% of 161 Inspections that it Has conducted.

Johnson & Johnson Recalls Continue

You gotta wonder how many More Inspections J&J would Flunk if the FDA were Really on the ball. At least now FDA Knows, and they'll get Right On It, or maybe not.

Prescription Drug User Fee Act (PDUFA) > PDUFA User Fee Rates Archive

The Same way they're holding Pharma Execs responsible for Knowing what their subordinates are doing.

The Park Doctrine: FDA Issues Their Position: "Like, Oh Well, Whatever"

PS: When we link to folks like Bloomberg, BNET, FierceHealthcare/Pharma, Pharmalot, et Al, Please click on through to them and visit their Advertisers. Help them pay the rent, OK?

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