Regulators mull pros, cons of transparency efforts

Regulator transparency has become a rallying cry on both sides of the pond. The European Medicines Agency has been advised by the European ombudsman to reconsider a request for information that it denied two years ago. The case concerns reports of adverse reactions to an acne drug.

In denying the request, the agency had argued that regulations outlining the granting of information excluded adverse event reports. The ombudsman disagreed, stating that the intent of the regulation was to cover all agency documents. In addition, granting the request, by providing greater EMA transparency, would improve Europeans' trust in the agency. It's up to the agency now to consider the ombudsman's recommendation.

In the U.S., as we've reported, the FDA continues its voluntary march toward transparency, led by Commissioner Margaret Hamburg. The regulator is awaiting public comments on 21 draft proposals, culled from 1,500 comments gathered as part of its transparency initiative.

- read the European ombudsman's draft recommendation

Suggested Articles

A biotech that worked with a nutritional products maker on the API for its clinical-stage radiation drug, is buying all of the manufacturing know-how.

Merck KGaA is selling a manufacturing site and its Allergopharma allergy drug business as it focuses on newer meds.

In a first, the FDA and Indian oversight agencies worked together to block illegal drugs from entering the U.S.