Lawmaker Urges SEC to Assess Requirements for Postmarketing Studies

A top Democratic representative is prodding the SEC to take a harder look at how pharmaceutical companies disclose information about postmarketing studies to shareholders.

Rep. Edward Markey (D-Mass.), senior member of the House Energy and Commerce Committee, recently sent a letter to SEC Chairman William Donaldson to inquire about the agency's views regarding the obligation of publicly traded companies to reveal postmarketing information.

"I am concerned that companies may not be fully reporting information regarding their obligation to carry out postmarketing studies, the status of such studies, the implications of a failure to complete the study, or of any adverse findings that might arise as a result of such studies," Markey wrote. He pointed to a March 2004 report issued by the FDA that indicated only 33 percent of postmarketing drug studies were proceeding on schedule.

"As a result, I am concerned that investors may be misled into believing that a company may be giving an impression to investors that drugs they produce have been fully approved by the FDA as safe and effective, when in fact the drug has been given only a conditional approval," Markey said.

Under the existing drug-approval process, the FDA grants accelerated approval to certain products, on the condition that the manufacturer commits to conducting an appropriate postmarketing confirmatory study. Under this process, a drug can be approved on the basis of preliminary studies, and the manufacturer does not have to meet standard FDA requirements for establishing the drug's safety and effectiveness, as long as that research is conducted in the postmarketing phase.