May 1, 2008

FDA Warns Merck To Correct Mistakes at Plant

In a warning letter sent to Merck & Co's CEO Richard Clark, and released publicly Wednesday, the Food and Drug Administration (FDA) ordered the company to rectify numerous manufacturing deficiencies at its main vaccine plant in West Point, Pa., just outside Philadelphia.

The letter was signed by David K. Elder, who leads enforcement in the agency's Office of Regulatory Affairs.  It said the FDA inspectors had found manufacturing rules were not being followed at the plant, which makes a number of children's vaccines and four for adults.

The nine-page letter said the agency found "significant objectionable conditions" during multiple inspections from Nov. 26 to Jan. 17 in the manufacture of vaccines and drug ingredients.

It's the latest in a chain of setbacks for Merck. Production of two vaccines made at the West Point plant -- Comvax, a combination vaccine for Haemophilus B and hepatitis B, and PedvaxHIB, which prevents Haemophilus influenza type B, was halted last year after a sterility problem was discovered in October.  1.2 million doses of the vaccines were recalled last December.

The West Point plant also makes ProQuad, a vaccine that protects children against measles, mumps, rubella and chickenpox; Gardasil, a cervical cancer vaccine; and hepatitis A, hepatitis B and meningitis vaccines for children and adults;

In a separate posting on its Web site, the FDA said it issued the warning letter because Merck's response to the agency's earlier post-inspection report was "inadequate to address the serious deviations noted."

The letter, heavily redacted, said Merck officials did not completely investigate after vaccine batches failed to meet specifications, even if batches had already been distributed.  Some combination measles-mumps-rubella shots that failed "visual inspection for critical defects" were distributed nonetheless, the letter said.

The agency further wrote that the plant had no written procedures, tests or other controls to ensure "identity, strength, quality, and purity" of its products.

However, the Web posting said the agency "does not believe that the issues identified will affect the safety of the vaccines" made at the West Point plant, or affect their availability.

"We're committed to working with the FDA to ensure that all these issues are addressed to their full satisfaction," Amy Rose, a Merck spokeswoman, told the Associated Press, adding that the company does not distribute contaminated products.

"We are confident in the quality, effectiveness and safety of our medicines and vaccines," she said.

Rose said the company would provide additional information to the FDA and review it the material during a follow up meeting requested by the agency in the letter.

Trampled by the FDA's rejection of  two of its experimental drugs since Friday, Merck shares initially declined $1 per share on the news, then later recovered, ending up 90 cents, or 2.4 percent, to $38.04 in Wednesday's trading.

The warning letter gives Merck 15 days to explain how the company will correct its violations.   If Merck does not respond, the FDA can suspend or revoke the plant's manufacturing license, seize products, or seek injunctions against product shipments, the letter said.

"Warning letters help achieve voluntary compliance," wrote Mary Long, an FDA spokeswoman, in an e-mail to the Associated Press.

"Further action can be taken in the event violations remain uncorrected and would depend on the details of a given situation."

The FDA letter can be viewed at http://www.accessdata.fda.gov/scripts/wlcfm/recentfiles.cfm.

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