On Friday, April 7, the Northern District of Texas issued a decision blocking the prescribing and dispensing of mifepristone nationwide. The court held that plaintiffs had a substantial likelihood of success on the merits regarding their arguments that the FDA approval of the drug in 2000 was arbitrary and capricious. Accordingly, the court stayed the … Continue Reading
The U.S. Food and Drug Administration (FDA) has issued new guidance to the medical device industry on the importance of cybersecurity measures in product development. The nonbinding guidance, titled “Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices Under Section 524B of the FD&C Act,” stresses the critical need for manufacturers to address … Continue Reading
FDA inspections of biopharmaceutical manufacturers often lead to the discovery of avoidable compliance issues. On today’s episode, Staying Ahead of the Curve in BioPharma: Navigating FDA Inspections, Drug Supply Chain Security Act (DSCSA) Implementation, and Supply Chain Disruptions, we discuss tips for avoiding common compliance issues discovered during FDA inspections and explore the upcoming implementation of … Continue Reading
On March 13 the FDA officially issued a Federal Register notice to explain how the end of the COVID-19 PHE declaration will impact the Agency’s 72 COVID-related guidance documents currently in effect. The notice comes as the Biden administration plans to end the PHE phase of the pandemic response on May 11. Of the 72 COVID-19-related guidance … Continue Reading
On Jan. 23, the Food and Drug Administration (FDA) finalized industry guidance for clinical research using cannabis and cannabis-derived compounds, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. The need for the guidance stemmed from the 2018 Farm Bill, which legalized the production and sale of hemp (cannabis below 0.3 percent delta-9 THC by … Continue Reading
On Jan. 3, the Food and Drug Administration (FDA) finalized a rule allowing more retail pharmacies to dispense abortion pills upon completion of a certification process. The FDA finalized the changes after reviewing supplemental applications from manufacturers of the drug mifepristone requesting modification of the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program. Read full … Continue Reading
SENATE COMMITTEES TO REVIEW TRUMP’S HHS PICK The year-end schedules of the Senate HELP and Finance committees just became more clogged, as the two panels will lead the review of President Trump’s nominee to be Health & Human Services (HHS) secretary. Trump announced this morning that he selected former HHS official Alex Azar as his … Continue Reading
House Plans CHIP Vote This Week but Final Action Not Likely Until December House Majority Leader Kevin McCarthy (R-Calif.) said lawmakers will vote this week on legislation to renew federal funding for the Children’s Health Insurance Program (CHIP), even amid unresolved partisan disagreements over how to pay for it. Republicans and Democrats on the House … Continue Reading
Alexander, Murray Seek Health Law Stabilization Agreement With congressional Republicans’ efforts to repeal the Affordable Care Act (ACA) on hold at least for now, the bipartisan leaders of the Senate HELP Committee are seeking to rekindle their work to shore up the health law’s troubled individual marketplace. Committee Chairman Lamar Alexander (R-Tenn.) said he hoped … Continue Reading
GOP Divisions Threaten to Sink ACA Repeal Effort – Again Republicans’ last-ditch effort to overhaul the Affordable Care Act (ACA) suffered potentially fatal blows as GOP senators in recent days voiced either outright opposition to or serious reservations about legislation pushed by Sens. Lindsey Graham (R-S.C.) and Bill Cassidy (R-La.). The senators’ bill would repeal … Continue Reading
Graham, Cassidy Push Last-Ditch Effort on ACA Repeal Republican senators pushing a last-ditch effort to overhaul the Affordable Care Act (ACA) say they are within one vote of having the support needed to pass their bill. Sens. Bill Cassidy (R-La.) and Lindsey Graham (R-S.C.) said they would continue to push for a vote this month … Continue Reading
ACA Stabilization Effort Continues Amid Uncertain Senate Fate The chairman of a Senate healthcare committee outlined a key test for stabilizing the Affordable Care Act’s (ACA) shaky individual marketplace: Both Republicans and Democrats will have to give a little. That formula has been wildly unsuccessful not only this year but also in recent years as … Continue Reading
Editor’s Note – The next Capitol Hill Healthcare Update will be published after Labor Day when Congress reconvenes following its August recess. Republicans Contemplate Next Steps Amid ACA Flameout Congressional Republicans and President Donald Trump face a series of key questions about how or whether to fortify the Affordable Care Act – particularly in the … Continue Reading
Senate Readies for Key Procedural Vote on Healthcare Bill – Maybe Senate Republicans face a key procedural vote this week that would allow for debate of their healthcare legislation, but significant uncertainty remains about whether GOP senators can meet that procedural hurdle, what the underlying healthcare bill would be and how an impending White House … Continue Reading
Senate Reconvenes but No Health Votes Expected This Week The Senate reconvenes today following the Fourth of July recess, but senators are at least a week away – and perhaps even longer – from voting on legislation to replace the Affordable Care Act (ACA). Familiar divisions continue to frustrate Republicans: how to deal with states … Continue Reading
On June 13, 2017, the U.S. Supreme Court issued its opinion in Sandoz v. Amgen. In doing so, it answered two questions raised under the Biologics Price Competition and Innovation Act of 2009 (BPCI). First, is an injunction available under federal law if the biosimilar applicant fails to provide its application and manufacturing information to … Continue Reading
CBO Score of House Health Bill Set for This Week Congress’s official budget scorekeepers this week will release analysis of the House-approved bill repealing most of the Affordable Care Act (ACA), and that data will inform Senate Republicans on a path for passing their version of the legislation. The Congressional Budget Office (CBO) and the … Continue Reading
Senate Panel OKs FDA User Fees Legislation reauthorizing FDA user fees for prescription and generic drugs, biosimilars, and medical devices won wide bipartisan approval last week in a Senate committee, teeing up approval by the full Senate, likely after the Memorial Day recess. The Senate HELP Committee approved the five-year renewal on a 21-2 vote. … Continue Reading
House approval last week of legislation repealing and replacing most of the Affordable Care Act (ACA) sets up a showdown in the Senate, where GOP leaders will confront a familiar web of political, policy and procedural obstacles that took House Republicans five months to navigate. Majority Leader Mitch McConnell and key committee chairmen must reconcile … Continue Reading
House Passes ACA Repeal and Replace Eight weeks after its introduction, legislation to “repeal and replace” the Affordable Care Act (ACA) won House approval today by a 217-213 vote. Vice President Mike Pence on Sunday said a vote in Congress to repeal the ACA was “just around the corner,” even as key House moderates continued … Continue Reading
GOP Struggles To Revive Health Bill House Republicans of all ideological stripes say they are committed to rekindling interest in the American Health Care Act (AHCA), but while the interest is real, so too are the policy and political divisions that thwarted passage of the bill last month. When House Speaker Paul Ryan and other … Continue Reading
AHCA Autopsy: What Happened, What’s Next? House Speaker Paul Ryan’s decision to cancel Friday’s vote on the American Health Care Act triggered post-mortem jockeying among vying GOP factions struggling to come to grips with how the party failed to repeal a law it has singularly campaigned against for the last seven years. Republicans’ inability to … Continue Reading
House Sets Thursday Vote on ACA Repeal House Republicans are scheduled to vote Thursday night on legislation to repeal most of the Affordable Care Act (ACA) even as GOP leaders scramble to secure the final votes needed to pass the bill. House leaders said publicly this weekend that they are confident the needed 216 lawmakers … Continue Reading
GOP leaders face pushback on new health plan Republican leaders on Capitol Hill face growing cross pressures from different factions of GOP lawmakers over their emerging legislation to replace the Affordable Care Act (ACA). Conservatives in the House and Senate want the legislation to speed up the phase-out of the ACA’s Medicaid expansion – as … Continue Reading