Drug Safety Developments

Waiting For Godot: Merck, The FDA And Post-Marketing Studies That Never Arrive

Quoted from http://www.forbes.com/sites/edsilverman/2012/02/29/waiting-for-godot-merck-the-fda-and-post-marketing-studies-that-never-arrive/

Waiting For Godot: Merck, The FDA And Post-Marketing Studies That Never Arrive

 

2/29/2012, Ed Silverman

Anyone who thought that the drug approval process could be easily improved by placing greater emphasis on post-marketing studies has only to look at a nasty clash between the FDA and Merck to realize the notion may be fraught with peril.

The agency, for those who did not follow the news, recently sent the drug maker a warning letter for failing to proceed with post-marketing studies for its Januvia and Janumet diabetes treatments. The studies were required to assess the risk of acute pancreatitis after 88 cases were reported between October 2006 and February 2009.

 The FDA had sent Merck a complete response letter in October 2009 to say that scrutinizing adverse events reports would not be sufficient to gauge the risk of acute pancreatitis and that, instead, a three-month pancreatic safety study in a diabetic rodent model treated with sitagliptin would be required. Januvia is also known as sitagliptin; Janumet combines this drug with metformin.

And so, a  timetable was established that required the drugmaker to submit a final protocol by June 15, 2010; followed by a study completion date on March 15, 2011, and a final report submission on June 15, 2011. Completing the three-month study was specified as a condition for supplemental new drug approvals from the FDA. Yet, Merck blew past each deadline.

Moreover, the drugmaker proposed to satisfy the post-marketing requirement by submitting study data from another independently conducted investigator-initiated study, not the agreed-upon studies required by the FDA. But even then, Merck was somehow unable to meet deadlines for submitting information.

[Article continues at original source]

Merck Warned by FDA on Failure to Study Januvia Treatment for Side Effects

Quoted from http://www.bloomberg.com/news/2012-02-28/merck-warned-by-fda-on-failure-to-study-januvia-treatment-for-side-effects.html

Merck Warned by FDA on Failure to Study Januvia Treatment for Side Effects

By Anna Edney - Feb 28, 2012 10:52 AM ET

Merck & Co. (MRK) may face fines after being almost a year late with a post-market study of its diabetes drugs Januvia and Janumet to determine if the pills inflame the pancreas, U.S. regulators said.

A letter posted today on the Food and Drug Administration’s website warned a subsidiary of the Whitehouse Station, New Jersey-based company that the diabetes medications are considered misbranded because Merck hasn’t completed a 3-month pancreatic safety study in rodents. Merck agreed to the study to gain expanded approval of the drugs and committed to completing it by March 15, 2011, according to the letter dated Feb. 17.

Merck will submit a design for a study to the FDA within 30 days of the date of the letter and start the trial within six months of the agency’s agreement on a protocol, Merck spokeswoman Pamela Eisele said. The company attempted to submit a 12-month independent study to the FDA to satisfy the post- market requirement, and the agency determined the data was insufficient, according to the letter.

“This violation is concerning from a public health perspective,” because the additional testing is to assess “a signal of a serious risk of acute pancreatitis, including necrotizing forms, associated with sitagliptin,” the main ingredient in both medicines, the letter states.

[Article continues at original source]

US FDA sees pancreatitis link with Merck's Januvia

Quoted from http://www.reuters.com/article/governmentFilingsNews/idUSN2550919420090925

US FDA sees pancreatitis link with Merck's Januvia

 

WASHINGTON, Sept 25 (Reuters) - U.S. health officials said on Friday they suspect Merck & Co Inc's diabetes drug Januvia may be linked to serious cases of pancreatitis, but company officials disputed the connection.

The Food and Drug Administration said that 88 cases of acute pancreatitis had been reported since the drug's approval in 2006 through February 2009.

Because a number of patients developed the condition soon after taking Januvia, or related drug Janumet, and about half saw it disappear after they stopped using it, "FDA believes there may be an association" with the drug.

But Dr. John Amatruda, a Merck senior vice president for diabetes products, said "We don't believe that the data establishes a relationship."

Both Januvia and Janumet contain the active ingredient sitagliptin.

The FDA said it was working with Merck to add information about the cases to the drugs' labels. (Reporting by Susan Heavey; Editing by Tim Dobbyn)