Medical experts fail new eye drop due to flawed clinical trials
SILVER SPRING, Md. A panel of medical experts deemed a proposed eye drop drug by River Plate Biotechnology as not safe nor effective enough to treat patients with dry-eye disease.
The vote was 6 to 1 against the product. The Food and Drug Administration will take the panel’s thoughts into consideration when making a final decision on whether to approve the drug.
If approved, River Plate’s Rejena will be used to treat dry-eye disease, which affects about 5 million people in the United States, the company said.
Allen Rutzen, a panel member who voted in favor of Rejena, said, “Although I’m not overly impressed with the data,” the drug did meet standards for approval.
Obama administration rejects long exclusivity periods for biotech drugs
WASHINGTON The Obama administration gave a boost to the generic drug industry Wednesday with a letter to Rep. Henry Waxman, D-Calif., rejecting calls by the biotech and pharmaceutical industries for guarantees of long market-exclusivity periods in biosimilars legislation.
The letter cited a recent Federal Trade Commission report saying that market exclusivity periods of 12 to 14 years were unnecessary to ensure innovation and competition, and that seven years would suffice. Signed by Office of Health Reform director Nancy-Ann DeParle and Office of Management and Budget director Peter Orszag, the letter was a response to Waxman’s June 8 letter responding to proposals for a regulatory approval pathway for biosimilars in the administration’s fiscal year 2010 budget.
The generic drug industry has welcomed the letter. “As Congress debates healthcare reform, the White House has sent a strong signal to members that it is critical to ensure that affordable, life-saving biogeneric medicines get to patients in need sooner rather than later,” Generic Pharmaceutical Association president and CEO Kathleen Jaeger stated. “In citing the recent FTC report on biogenerics, the president rejects attempts by the pharmaceutical and biotech industries to needlessly extend market exclusivity provisions to an unprecedented period of 12 to 14 years simply to maintain their monopolies on biopharmaceutical products.”
Meanwhile, the organization representing the biotech industry criticized the letter, calling seven years’ market exclusivity a “risky short cut” to biosimilars. “As we have consistently said, any pathway to biosimilars should provide a fair period of time for innovators to protect their proprietary data from competitors in order to promote the continued development of breakthrough medicines, therapies and cures,” Biotechnology Industry Organization president and CEO Jim Greenwood said. “We continue to believe that 14 years of data exclusivity will strike the appropriate, reasonable and fair balance between our common desire to expand access to breakthrough biotech medicines and the need to preserve the protections necessary to promote further biomedical advances.”
U.S. Marshals seize drugs from Caraco Pharmaceutical Labs
ROCKVILLE, Md. U.S. Marshals seized drugs made by generic manufacturer Caraco Pharmaceutical Labs Thursday at the company’s Michigian plants in Detroit, Farmington Hills and Wixom, at the request of the Food and Drug Administration.
The FDA said the seizure resulted from violations of the agency’s current Good Manufacturing Practice requirements by the company. Since January, Caraco has voluntarily recalled drugs due to potential manufacturing defects, including formulation errors and oversized tablets. The FDA found unresolved violations of cGMP requirements during an inspection of Caraco’s Detroit plant in May, the company said.
“The FDA will continue to take swift, aggressive enforcement action when firms are identified as being in violation of our manufacturing requirements,” FDA associate commissioner for regulatory affairs Michael Chappell stated.
In a statement on the seizure, Caraco said it had taken corrective actions and was making “continual improvements,” noting that the seizure did not affect products made outside of Michigan.