Merck’s Manufacturing Problems Subsiding

August 1, 2008

Merck has resolved a warning letter citing good manufacturing practice violations at its vaccine operations in West Point, Pa.

During its second-quarter earnings call, the company said that the FDA closed out a warning letter that claimed bulk drug substances for many of Merck’s vaccines were adulterated. The letter resulted from an inspection that cited 49 Form 483 observations, all but 12 of which were resolved before the letter was issued, the company said.

“On July 10, Merck received a letter from the FDA closing out its recent inspection at the West Point manufacturing facility. As a result, any filed sBLAs which were held up due to the inspection can now move through the agency’s normal review and approval process,” Merck CEO Dick Clark said.

“Concerning supplements, we have at least two supplements with the FDA concerning Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] and they will move through the [review] process,” he said.

Merck said the supplements are for expanded labeling for Gardasil. The company will respond to an FDA complete response letter for the use of the vaccine in women 27–45 years of age.