Pathway for Biosimilars Act gives agencies ‘flexibility’
May 1, 2008
9:22 pm
Rep. Anna Eshoo (D-CA) and Rep. Joe Barton (R-TX) have introduced legislation that would create a regulatory pathway for the FDA to approve follow-on or generic biologics.
HHS committee to recommend lab test oversight
May 1, 2008
9:20 pm
As DTC promoters push all kinds of genetic tests, a high-level HHS advisory committee is preparing to recommend that FDA should have some level of oversight for all lab tests, including the more than 1,100 genetic tests now offered by hundreds of labs across the nation.
Judge: branded companies may be liable for generic versions
May 1, 2008
9:04 pm
Philadelphia Common Pleas judge Mark Bernstein has ruled that branded drug companies may be liable for money spent on the generic version of their drugs when it is marketed for off-label uses.
Sen. Edward Kennedy (D-MA) says the FDA should build databases to enable it to determine where drug companies obtain their ingredients and what they are doing to ensure the ingredients are pure and potent.
Sen. Charles Grassley (R-IA) says he is concerned that the FDA’s Safety First initiative is merely cosmetic and will not make fundamental changes he says are needed to improve FDA’s oversight of approved drugs.
The FDA’s director of new drugs, John Jenkins, has told his reviewers that they may miss Prescription Drug User Fee Act (PDUFA) deadlines by up to two months and decline some sponsor meeting requests, among other steps to manage workload and staff shortages.
Kessler: FDA pre-emption is of no benefit to public
FDA pre-emption of “failure-to-warn” state lawsuits over drug risks does nothing to benefit the agency or the public and can prevent information that is helpful to the FDA, healthcare providers, and consumers from coming out, say commissioner David Kessler and Georgetown Law professor David Vladeck in the Georgetown Law Journal.
A subpoenaed FDA criminal investigator has told Congress that Aventis should have known that data it submitted to support the approval of antibiotic Ketek was fraudulent.
Leavitt: foreign companies deny access for US officials