FDA warns Merck over problems at West Point plant

Federal regulators warned Merck & Co. Inc. today that it must fix recurring manufacturing problems at its West Point vaccine plant or face harsher action.

The warning letter from the U.S. Food and Drug Administration cited Merck for failing to follow good manufacturing practices and allowing recurrent problems documented during recent inspections, such as vaccine vials with unwanted "fibers."

The agency sent the warning letter, addressed to Merck chief executive officer Richard T. Clark, because it did not believe the company was moving fast enough to correct past problems, said Mary "Peper" Long, an FDA spokeswoman.

"We need corrective action immediately," she said.

The company, whose West Point products range from childhood vaccines for measles to the relatively new vaccine Gardasil for cervical cancer, has 15 days to detail its corrective actions.

The FDA could take court action if its concerns are not met. In extreme cases, it can shut down a plant or individual production lines, although a former official said that appeared unlikely in this case.

The agency also is requesting a meeting with senior Merck managers to discuss the letter and learn how the company will respond.

John T. McCubbins, who heads Merck's Global Vaccine Manufacturing and West Point Operations, will be among those meeting with the FDA, Merck spokeswoman Amy Rose said.

"The warning letter doesn't raise any new issues," Rose said. "It is a continuation of the issues and concerns cited in the FDA's original report. We take the observations and the warning letter very seriously, and we are committed to addressing all the FDA's concerns in a timely and comprehensive manner."

She reiterated that most of the production problems cited by the FDA were caught by Merck staff and that no contaminated vaccines were released to the public. The company stands behind the quality of its vaccines, she said.

The warning letter comes as the number of such FDA enforcement actions has dropped dramatically, from 1,154 in 2000 to 538 in 2006, according to the agency's Web site.

At the same time, the agency - responding to recalls ranging from tainted pet food to the blood thinner heparin - announced today that it would fill 1,300 positions by the end of September, mostly in new drug-review areas and for field inspectors who cover manufacturing plants and food companies. The agency employs more than 10,000 people.

Merck's Montgomery County plant has been under pressure. Its vaccine products are much in demand. The company's vaccine sales surged from $1.1 billion in 2005 to $4.3 billion in 2007, even as production problems have been cropping up.

Bulk production of varicella-related vaccine for chicken pox has been down for many months, leading to shortages. The supply of Vaqta for hepatitis A also has been disrupted. And in December 2007, the company announced a recall of 1.2 million doses of its childhood vaccines PedvaxHIB and COMVAX because plant executives could not guarantee the products' sterility.

FDA inspectors spent a total of 30 days at the West Point plant between Nov. 26, 2007, and Jan. 17, 2008, and found 45 areas of concern. The FDA inspection report was obtained by The Inquirer in late April through a Freedom of Information Act request from the agency.

The FDA warning letter, posted today on the agency's Web site, said the company had failed to ensure that equipment for manufacturing and processing was "calibrated, inspected or checked according to a written program designed to assure proper performance."

"Failures are not fully investigated and documented" in the vaccine-making process, the letter said.

The FDA specifically cited unwanted fibers that were showing up on vial stoppers for such vaccines as MMR, or measles, mumps and rubella. These stoppers are placed in special bags for sterilization. The FDA said the company was using "lesser quality" bags that were breaking down slightly and producing the fibers.

The FDA criticized the company for throwing out just the product where the fibers were found. The company should have assessed all potentially affected products, the FDA said.

In a Q&A on its Web site, the FDA said it "does not believe that the issues identified will affect the safety of the vaccines manufactured by Merck."

The FDA also said it did not expect the deficiencies to affect availability of the firm's vaccines, except for PedvaxHIB and COMVAX, which were recalled.

Sammie Young, a retired FDA deputy director who oversaw the agency's vaccine-plant inspections, said he believed the warning letter had put the company "on a track to prosecution."

"It depends on how much stuff they correct," Young said. He acknowledged that the agency rarely used its injunction powers to shut down a plant, especially one so critical to children's health.

Merck, based in Whitehouse Station, N.J., and employing more than 10,000 people in Montgomery County, has seen its finances improve in recent years since the withdrawal of Vioxx in September 2004. But the company also has seen a recent run of bad news, including a drop in sales of the cholesterol-fighting drug Vytorin and the recent decision by the FDA not to approve Merck's newest heart medicine, Cordaptive, or its Singulair-Claritin combination for nasal congestion.

Merck shares have fallen about 31 percent this year. "They've had a rash of bad luck," said Daniel Hoffman, a pharmaceutical analyst in Glenmoore, Chester County.

Even so, today's news did not faze investors more focused on ongoing issues that affect revenue. Merck shares closed at $38.04, up 2.42 percent.