Tag Archives: FDA

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

Lee H. RosebushLindsay 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

Mike FergusonChris JonesAdam HigginsTyler 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

Mike FergusonChris JonesAdam HigginsTyler 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

Mike FergusonChris JonesAdam HigginsTyler 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

Mike FergusonChris JonesAdam HigginsTyler 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

Mike FergusonChris JonesAdam HigginsTyler 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

Elizabeth O’ConnellLee 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

Mike FergusonChris JonesAdam HigginsTyler 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

Capitol Hill Healthcare Update

Mike FergusonChris JonesAdam HigginsTyler ThompsonBy Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on 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

Mike FergusonChris JonesAdam HigginsTyler ThompsonBy Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on 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

Lee H. RosebushLindsay HolmesBy Lee H. Rosebush, Lindsay Holmes and Allison Rochford on 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

Lee H. RosebushLindsay HolmesBy Lee H. Rosebush, Lindsay Holmes and Allison Rochford on 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

Capitol Hill Healthcare Update

Mike FergusonChris JonesAdam HigginsTyler ThompsonBy Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on Posted in Uncategorized
House Oks “Cures,” Senate Votes This Week The Senate this week is likely to give final congressional approval to legislation that adds billions of dollars for biomedical research and aims to speed the discovery and development of new drugs and medical devices. The “21st Century Cures” legislation won House approval last week 392-26. Although several … Continue Reading

Capitol Hill Healthcare Update

Mike FergusonChris JonesAdam HigginsTyler ThompsonBy Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on Posted in Uncategorized
Congress Adjourns, Eyes Election Then Lame Duck Congress completed work last week on a stopgap budget that keeps the government open until a post-election lame-duck voting session in December, when lawmakers are expected to move on legislation dealing with medical innovation, mental health reform and possibly efforts to stop CMS’s proposed Medicare Part B drug … Continue Reading

Capitol Hill Healthcare Update

Mike FergusonChris JonesAdam HigginsTyler ThompsonBy Mike Ferguson, Chris Jones, Adam Higgins and Tyler Thompson on Posted in Uncategorized
New Bill Targets Drug Prices Bipartisan legislation introduced in the Senate last week would require pharmaceutical manufacturers to alert the U.S. Department of Health and Human Services (HHS) before increasing prices more than 10 percent, continuing congressional pressure on the industry over drug pricing. The bill’s authors – including Sen. John McCain, (R-AZ) – say … Continue Reading

Pharmaceutical Life Cycle Management: Navigating the New IP, FDA, and Antitrust Terrain

By BakerHostetler on Posted in Uncategorized
Efforts to extend the life cycle of pharmaceutical products frequently involve innovations and improvements in product design, formulation, route of administration and treatment indications. In addition, negotiation of agreements with competitors, including generic and biosimilar manufacturers, is frequently employed as part of a life cycle management strategy. However, recent changes in patent, regulatory, and antitrust … Continue Reading

Increased Scrutiny of Drug Pricing – What Should Pharmaceutical Companies Know

Lee H. RosebushNita GargLindsay HolmesBy Lee H. Rosebush, Nita Garg and Lindsay Holmes on Posted in Uncategorized
As U.S. spending on pharmaceuticals continues to rise, reaching $373.9 billion in 2014, government scrutiny of drug pricing practices has increased in response. Early last year, the U.S. Department of Health and Human Services Office of Inspector General (OIG) received a request from Rep. Elijah Cummings (D-Md.) and Sen. Bernie Sanders (I-Vt.) that the government … Continue Reading

FDA Issues Guidance on Cybersecurity Issues for Postmarket Medical Devices

Lance L. SheaJoel GottesmanBy Lance L. Shea and Joel Gottesman on Posted in Uncategorized
On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance on cybersecurity risks associated with medical devices, and addressed steps that device manufacturers should take to mitigate such risks. The guidance, titled Postmarket Management of Cybersecurity in Medical Devices (Postmarket), is intended to clarify the FDA’s recommendations and emphasize the importance of monitoring, identifying, … Continue Reading
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