Ortho recalls vials of Procrit
NEW BRUNSWICK, N.J. Johnson & Johnson’s subsidiary Ortho Biotech is recalling more than 44,000 vials of the erythropoiesis-stimulating agent Procrit because its post-manufacturing inspection found cracks in a small number of vials.
Only one lot is being recalled. It was distributed by J&J’s JOM Pharmaceutical Services warehouse between April 15 and July 17.
Other Procrit lots distributed by JOM are not affected by the recall, which is being conducted in cooperation with the FDA, the company said. The amount being recalled is a small portion of the Procrit in distribution, and no supply disruptions are anticipated.
“Vials exhibiting even slight cracks may not maintain their sterile condition and should not be for subcutaneous or [IV] injection,” Ortho Biotech said.
FDA new response procedure could confuse investors
WASHINGTON The Food and Drug Administration’s decision to change how it responds to drug companies’ submissions for drug applications is not only affecting the companies, but investors as well, according to Reuters.
The approach could cloud a drug review process already growing less predictable as global pharmaceutical companies find less success winning U.S. approval for new products. The policy “may not give as much visibility to the direction the FDA is going,” Morningstar analyst Damien Conover said.
In the past, an approvable letter told companies their applications could be cleared if certain conditions were met. A not-approvable letter was seen as a sign of more serious problems.
The complete response letters will spell out what drugmakers could do to win approval, the FDA said.
But the agency by law must keep the letters confidential. Investors must rely on the companies, which often disclose only the type of letter received and give little detail about the FDA’s complaints. Manufacturers typically do not release a letter’s actual text.
Based on those facts, investors will now be guided by the companies as to what happens to a drug that could be a potential blockbuster on the market.
Insmed ceo lobbies for follow-on biologics rule
WASHINGTON The chief executive of a biotech company in Richmond, Va., wants to make it possible to get generic biologic drugs approved, the Washington Post reported Wednesday.
Geoffrey Allan, chief executive officer of Insmed, has been lobbying members of Congress in an effort to teach them the differences between chemical and biotech drugs. Allan hopes his company will become the first United States company to develop generic biologic drugs, also called “biosimilars.”
While the market for generic chemical drugs is expanding, there is no way to get generic biologic drugs approved. Allan hopes that Congress will change the laws to make generic biologic drug competition possible.