By Efthimios Parasidis One week prior to the Supreme Court’s landmark ruling in the health care cases, Democrats and Republicans overwhelmingly voted in favor of health-related legislation (387-5 House; 96-1 Senate). Industry and HHS were quick to congratulate our elected officials on a triumphant bipartisan achievement, while the FDA enthusiastically welcomed its latest collaboration with Big…
By Holly Fernandez Lynch Our friends over at the New England Journal of Medicine just alerted us to a new perspectives piece addressing the impact of cutting family planning funds in Texas (the piece was also picked up by Politico). The authors interviewed 56 leaders of organizations throughout the state that provided reproductive health services using…
by Jonathan J. Darrow A research study reported today in the New England Journal of Medicine found that physicians are able to discriminate between clinical trials with high levels of rigor versus those with low levels of rigor, as well as between clinical trials that are funded by industry and those that are funded by…
By Adriana Benedict Last week, Public Citizen published a Health GAP analysis entitled “Leaked TPP Investment Chapter Presents a Grave Threat to Access to Medicines,” in which Professor Brook Baker explains four ways in which access to medicines is compromised by the USTR’s leaked investment chapter proposal for the Trans-Pacific Partnership Agreement. The problematic provisions…
By Patrick O’Leary Back in February, President Obama’s FY 2013 budget authorized $4.5 billion for the Food and Drug Administration (FDA), about $2 billion of which was to come from user fees, the fees paid by regulated industry under a variety of schemes including the Prescription Drug User Fee Act (PDUFA), the Medical Device User…
by Nadia N. Sawicki The D.C. Circuit’s recent decision vacating the FDA’s graphic labeling requirements has prompted a flood of valuable commentary about compelled speech doctrine, including Richard Epstein’s, below. While analysis of the First Amendment issues is important, I view the R.J. Reynolds case instead as an example of how emphasis on formal legal…
By Hyeongsu Park In May 2012, Health Canada granted market authorization for Prochymal. This decision is the world’s first regulatory approval of a stem cell drug (as well as the first therapy for acute graft-vs-host disease, a serious complication of bone marrow transplantation that kills up to 80% of children affected). Like Prochymal, many stem…
By Katie Booth The FDA Law Blog has just published a semi-serious study by Kurt Karst on the growth of Title 21 of the United States Code (“USC”) compared to Title 21 of the Code of Federal Regulations (“CFR”) over the past twelve years. Title 21 governs food and drug law. Karst used the PDFs of…
by Jonathan J. Darrow The expiration of the patent on $11-billion-per-year Lipitor® (atorvastatin calcium) last November received wide media attention and was eagerly greeted by consumers, reflecting public excitement that seems to have not yet dissipated. In the following months, prices “plunged from about $175 a month for Lipitor to about $15 for generics,” according…
[posted on behalf of Richard Epstein] The entire question of the FDA’s tobacco regulation is likely to spur extended commentary, given the split of opinions between the D.C. Circuit, which knocked out the packaging labels by a divided vote in RJ Reynolds v. FDA, and the earlier decision in the Sixth Circuit, that sustained the regulation. …
