Tag Archives: FDA

FDA Issues Guidance on Clinical Research with Cannabis

Photo of Lee H. RosebushPhoto of Randal M. ShaheenPhoto of Winston S. KirtonPhoto of Laura MacherelliBy Lee H. Rosebush, Randal M. Shaheen, Winston S. Kirton and Laura Macherelli on Posted in Alert
CBD oil conceptOn 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

FDA Approves Abortion Pill for Sale by Retail Pharmacies

Photo of Amy FoutsPhoto of Claire BassBy Amy Fouts and Claire Bass on Posted in Alert
Pharmacist and customer discussing prescription in pharmacyOn 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

Capitol Hill Healthcare Update

Photo of Mike FergusonPhoto of Chris JonesPhoto of Adam HigginsPhoto of Tyler ThompsonBy Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on Posted in Uncategorized
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

Capitol Hill Healthcare Update

Photo of Mike FergusonPhoto of Chris JonesPhoto of Adam HigginsPhoto of Tyler ThompsonBy Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on Posted in Uncategorized
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

Capitol Hill Healthcare Update

Photo of Mike FergusonPhoto of Chris JonesPhoto of Adam HigginsPhoto of Tyler ThompsonBy Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on Posted in Uncategorized
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

Capitol Hill Healthcare Update

Photo of Mike FergusonPhoto of Chris JonesPhoto of Adam HigginsPhoto of Tyler ThompsonBy Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on Posted in Uncategorized
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

Capitol Hill Healthcare Update

Photo of Mike FergusonPhoto of Chris JonesPhoto of Adam HigginsPhoto of Tyler ThompsonBy Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on Posted in Uncategorized
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

Capitol Hill Healthcare Update

Photo of Mike FergusonPhoto of Chris JonesPhoto of Adam HigginsPhoto of Tyler ThompsonBy Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on Posted in Uncategorized
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

Branded Biologic Products Lose 180 Days of Patent Exclusivity in Unanimous Decision From Supreme Court

Photo of Lee H. RosebushPhoto of Lindsay HolmesBy Lee H. Rosebush and Lindsay Holmes on Posted in Uncategorized
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

Capitol Hill Healthcare Update

Photo of Mike FergusonPhoto of Chris JonesPhoto of Adam HigginsPhoto of Tyler ThompsonBy Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on Posted in Uncategorized
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

Capitol Hill Healthcare Update

Photo of Mike FergusonPhoto of Chris JonesPhoto of Adam HigginsPhoto of Tyler ThompsonBy Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on Posted in Uncategorized
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

Capitol Hill Healthcare Update

Photo of Mike FergusonPhoto of Chris JonesPhoto of Adam HigginsPhoto of Tyler ThompsonBy Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on Posted in Uncategorized
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

Capitol Hill Healthcare Update

Photo of Mike FergusonPhoto of Chris JonesPhoto of Adam HigginsPhoto of Tyler ThompsonBy Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on Posted in Uncategorized
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

Capitol Hill Healthcare Update

Photo of Mike FergusonPhoto of Chris JonesPhoto of Adam HigginsPhoto of Tyler ThompsonBy Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on Posted in Uncategorized
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

FDA Publishes Guidance on Off-Label Use Communications

Photo of Lee H. RosebushBy Elizabeth O’Connell and Lee H. Rosebush on Posted in Uncategorized
The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents and a memorandum related to off-label communications and the FDA’s power to regulate such communications. The publications are the FDA’s response to years of conflict between drug makers, which contend they have a first amendment right to communicate off label or information … Continue Reading

Capitol Hill Healthcare Update

Photo of Mike FergusonPhoto of Chris JonesPhoto of Adam HigginsPhoto of Tyler ThompsonBy Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on Posted in Uncategorized
At HHS, Price will lead Trump’s efforts on ACA repeal Three weeks into President Trump’s administration, the Senate on Friday narrowly approved Tom Price as Secretary of the U.S. Department of Health and Human Services (HHS), elevating the former orthopedic surgeon as Trump’s point person on repealing and replacing the Affordable Care Act (ACA). Price … Continue Reading
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