Tag Archives: FDA

Capitol Hill Healthcare Update

By Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on October 2, 2017 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

By Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on September 25, 2017 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

By Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on September 18, 2017 Posted in Uncategorized

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

Capitol Hill Healthcare Update

By Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on September 11, 2017 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

By Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on July 31, 2017 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

By Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on July 24, 2017 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

Capitol Hill Healthcare Update

By Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on July 10, 2017 Posted in Uncategorized

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

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

By Lee H. Rosebush and Lindsay Holmes on June 16, 2017 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

By Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on May 23, 2017 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

By Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on May 19, 2017 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

By Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on May 9, 2017 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

By Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on May 4, 2017 Posted in Uncategorized

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

Capitol Hill Healthcare Update

By Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on April 7, 2017 Posted in Uncategorized

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

Capitol Hill Healthcare Update

By Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on March 27, 2017 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

By Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on March 21, 2017 Posted in Uncategorized

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

Capitol Hill Healthcare Update

By Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on March 13, 2017 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

By Elizabeth O’Connell and Lee H. Rosebush on March 9, 2017 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

By Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on February 28, 2017 Posted in Uncategorized

Trump’s speech: Clarity on ACA next steps? President Trump will address a joint session of Congress on Tuesday, and the expectation is that he will use the primetime moment to outline – at least in broad strokes – his goals for repealing and replacing the Affordable Care Act (ACA), according to congressional staff. But it’s … Continue Reading

Capitol Hill Healthcare Update

By Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on February 24, 2017 Posted in Uncategorized

GOP still adrift on ACA repeal-replace plans Meeting privately with Senate Republicans to discuss next steps on the ACA was among the first actions taken last week by the new Secretary of the U.S. Department of Health and Human Services Tom Price. But GOP senators left the meeting disappointed that President Trump’s point man on … Continue Reading

Capitol Hill Healthcare Update

By Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on February 13, 2017 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

Capitol Hill Healthcare Update

By Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on February 6, 2017 Posted in Uncategorized

GOP leaders delay ACA action amid “repeal,” “repair” debate House Speaker Paul Ryan last week set a deadline of the end of March for repealing most of the Affordable Care Act (ACA), as other Republican leaders and conservative rank-and-file lawmakers advocated competing policy alternatives for what would follow the health law. Congressional Republicans had hoped … Continue Reading

Capitol Hill Healthcare Update

By Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on January 30, 2017 Posted in Uncategorized

At GOP retreat, consensus on healthcare elusive House and Senate Republicans emerged from a policy retreat last week in Philadelphia with no agreement on next steps in their plan to repeal and replace the Affordable Care Act (ACA). Most congressional leaders, including House Energy and Commerce Committee Chairman Greg Walden (R-Ore.), urged rank-and-file lawmakers to … Continue Reading

Human Drug Compounding: FDA Issues Four Guidance Documents

By Lee H. Rosebush, Lindsay Holmes and Allison Rochford on January 16, 2017 Posted in Uncategorized

FDA had a busy holiday season, issuing two final guidance documents and two draft guidance documents for industry related to human drug compounding right before the start of the new year. These guidance documents cover prescription requirements under Section 503A of the Federal Food, Drug, and Cosmetic Act (FFDCA); compounding and repackaging of radiopharmaceuticals; and … Continue Reading

21st Century Cures: Ambitious Medical Innovation Bill Has Broad Focus

By Lee H. Rosebush, Lindsay Holmes and Allison Rochford on December 19, 2016 Posted in Uncategorized

In a health policy landscape fraught with partisan rancor, congressional members from both sides of the aisle came together to pass the 21st Century Cures Act. Championed over the past three years by bill sponsor and House Energy and Commerce Committee Chairman Fred Upton (R-MI), the Cures Act primarily overhauls the FDA’s drug and device … Continue Reading