Tag Archives: FDA

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The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents and a memorandum related to off-label communications and the FDA’s power to regulate such communications.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

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 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

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 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

Photo of Lee H. RosebushPhoto of Lindsay 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

Photo of Lee H. RosebushPhoto of Lindsay 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

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 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

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
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

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
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

Photo of BakerHostetlerBy 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

Photo of Lee H. RosebushPhoto of Lindsay 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

Photo of Lance L. SheaPhoto of Joel D. GottesmanBy Lance L. Shea and Joel D. 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

First Amendment Right to Off-Label Promotion – Has Pandora’s Box Been Opened for FDA?

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
A handful of recent court decisions, including one issued just last month, seems to have potentially cracked open the door for pharmaceutical manufacturers to have more leeway to promote off-label uses of their products. Following on the heels of the Amarin case, another drug maker recently filed a lawsuit that may be the first of … Continue Reading

How Far Is Too Far? Court Rules for Amarin in Off-Label Marketing Fight against FDA

Photo of Lee H. RosebushBy Lee H. Rosebush and Nita Garg on Posted in Uncategorized
Drugmaker Amarin Pharma, Inc. (Amarin), recently received a victory in its fight against the Food and Drug Administration (FDA). On August 7, 2015, the U.S. District Court for the Southern District of New York ruled that Amarin has a constitutional right to make certain “truthful and non-misleading” statements regarding unapproved uses of its drug, Vascepa. … Continue Reading

FDA Investigates Children’s Cough and Cold Medication With Codeine Amid Safety Concerns

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
In the wake of the European Medicines Agency’s (EMA) recently announced warning against giving codeine to children under 12 years old, the FDA announced its own safety investigation of the drug for use in children. The FDA’s renewed interest in pediatric codeine use comes two years after the agency issued a black box warning, its … Continue Reading

House Passes 21st Century Cures Act

Photo of Lance L. SheaBy Lance L. Shea and Nita Garg on Posted in Uncategorized
On July 10, 2014, the U.S. House of Representatives overwhelmingly passed legislation intended to speed the approval of drugs and medical devices and increase funding for medical research. The central aim of H.R. 6, the “21st Century Cures Act” (Cures bill), is to accelerate the drug development process by reducing or removing regulatory obstacles. Specifically, … Continue Reading

Pharmacy Benefit Manager Group Opposes 21st Century Cures Act’s Cost Offset

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
The trade coalition representing pharmacy benefit managers is raising concerns about major bipartisan legislation aimed at streamlining the approval of new medicines and medical devices. However, the Pharmaceutical Care Management Association’s (PCMA) opposition to the legislation is not about the content of the bill but rather how Congress intends to pay for it. The 21st … Continue Reading

21st Century Cures Act Passes House Committee

Photo of Lance L. SheaBy Lance L. Shea and Nita Garg on Posted in Uncategorized
The House Energy and Commerce Committee unanimously approved H.R. 6, the “21st Century Cures Act,” on May 21, 2015, after reaching a bipartisan agreement to fund the legislation (Cures bill). Often described as a “landmark medical innovation” bill, key provisions of the Cures bill are intended to speed marketing approval of drugs and medical devices. … Continue Reading

Otsuka Suit Results in Victory for FDA

Photo of Lee H. RosebushBy Lee H. Rosebush and Nita Garg on Posted in Uncategorized
According to a recent decision by a Maryland federal court, the Food and Drug Administration (FDA) acted permissibly when it approved generic versions of Otsuka Pharmaceutical Co. Ltd.’s (Otsuka) product Abilify even though Otsuka retained marketing exclusivity for the drug. This ruling was the most recent in a series of decisions regarding the FDA’s decision … Continue Reading

FDA Committee to Continue Considering Drug Compounding Issues

Photo of Lee H. RosebushBy Lee H. Rosebush and Dena Kessler on Posted in Uncategorized
The advisory committee tasked with providing advice on medical, scientific and technical issues to the Food and Drug Administration (FDA) on compounded drugs is slated to continue its examination of matters concerning access to investigational new drugs and what components can be used in compounded products, among other topics. The FDA’s Pharmacy Compounding Advisory Committee … Continue Reading

FDA Addresses Compounding of Animal Drugs From Bulk Drug Substances

Photo of BakerHostetlerBy BakerHostetler on Posted in Uncategorized
The U.S. Food and Drug Administration (FDA) has released a Notice of Draft Guidance and Withdrawal of Compliance Policy Guidance (Guidance Notice), along with a Draft Guidance for Industry (Draft Guidance) addressing compounding of animal drugs from bulk drug substances. A separate Notice announced that FDA is soliciting nominations for the Bulk Drug Substance List … Continue Reading
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