It’s been 25 years since the U.S. FDA issued a final guidance on informed consent and nine years since it asked for comments on a draft guidance to supersede that 1998 guide.
As a U.S. appeals court ruling that restores the original restrictions the FDA imposed on the abortion drug mifepristone in 2000 heads to the Supreme Court for what will likely be full argument, the Biden administration continues to insist that the courts have no business overriding the FDA’s “scientific, evidence-based decisions.” Commenting on the Aug. 16 opinion from the U.S. Court of Appeals for the Fifth Circuit, which reinstated the original use restrictions, Vice President Kamala Harris said, “It endangers our entire system of drug approval and regulation by undermining the independent, expert judgment of the FDA.”
It’s been 25 years since the U.S. FDA issued a final guidance on informed consent and nine years since it asked for comments on a draft guidance to supersede that 1998 guide.
Often when the U.S. FDA’s Office of Prescription Drug Promotion (OPDP) determines that the marketing of a drug crosses the line of misbranding, it hands the sponsor an untitled letter schooling it on how the promotional materials run afoul on safety or efficacy claims.
A recent bipartisan request for funding of a study on replacing U.S. drug patents with cash prizes is just one more symptom of a larger global malady that makes patents the scapegoat for bigger problems that have nothing to do with intellectual property (IP), David Kappos, board co-chair of the Council for Innovation Promotion (C4IP), told BioWorld.
How long does it take for a U.S.-based biopharma company to complete a bankruptcy? In the case of privately held Purdue Pharma LP, the answer is likely five years or longer, depending on when the Supreme Court rules on the matter and whether it orders a do-over. The Supreme Court is the next chapter in the court saga that began in 2019 when the Stamford, Conn.-based company filed for bankruptcy in its first step toward reorganizing as a public benefit company.
A recent bipartisan request for funding of a study on replacing U.S. drug patents with cash prizes is just one more symptom of a larger global malady that makes patents the scapegoat for bigger problems that have nothing to do with intellectual property (IP), David Kappos, board co-chair of the Council for Innovation Promotion (C4IP), told BioWorld.
“Show us your work” is basically the message the U.S. Court of Appeals for the Federal Circuit sent to the Patent Trial and Appeal Board (PTAB) when it vacated a decision by the board in an ex parte review of rejected patent claims submitted by Theripion Inc. While the Aug. 10 Federal Circuit opinion that remanded the case is nonprecedential, the appellate court made it clear that the PTAB must explain its reasoning for whatever conclusions it reaches.
In a balancing act between supply and drug quality, the U.S. FDA tipped the scales on behalf of quality, slapping an import alert on Intas Pharmaceuticals Ltd. in June, followed by a July 28 warning letter requiring the India-based company to develop and implement a global corrective action and preventive action plan.
Even as biopharma challenges to the constitutionality of the “excise tax” included in the Inflation Reduction Act await action in the U.S. federal court system, the Treasury Department and the Internal Revenue Service (IRS) said they intend to issue proposed regulations to implement the tax.
