FDA Attorney Edward Allera Quoted on Drug Approval Setbacks for AMAG

Edward John Allera, chairman of the Buchanan Ingersoll & Rooney's FDA/Biotechnology Section and a managing shareholder of the firm's Washington, D.C., office, was quoted in an April 20, 2009, article published by Pharmawire. The article, titled "AMAG's Feraheme could face more approval delays on manufacturing front — analysis," reported on possible delays for AMAG Pharmaceuticals' Feraheme, "a drug in development for the treatment of iron deficiency anemia in chronic kidney disease patients."

According to the article, "AMAG received a Complete Response Letter on December [23] following the company's Class 1 resubmission as a response to an October 2008 Complete Response Letter. The letter indicated the company needed data to clarify a CMC (chemistry, manufacturing and controls) question, resolution of deficiencies observed during preapproval inspection of the company's manufacturing facility, and finalization of labeling discussions."

As a result of the letter, experts believe that AMAG could run into more delays. "[W]hen companies experience early clinical hurdles, it can get distracted from managing the operational side," said one FDA expert.

As noted in the article, "According to Allera, an administration change historically has led to ripples in the manufacturing inspection process at the FDA. With the previous administration, field staff believed they were restrained in taking action against companies, but that restraint has been lifted, he said. The shrinking budget and the opportunity to regain power in the field translate to a greater sensitivity in how investigators handle manufacturing approvals."