Lee H. Rosebush

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Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products

Photo of Winston S. KirtonPhoto of Lee H. RosebushPhoto of Lynn SessionsPhoto of Laura MacherelliPhoto of Marc WagnerBy Winston S. Kirton, Lee H. Rosebush, Lynn Sessions, Laura Macherelli and Marc Wagner on Posted in FDA
On May 10, the U.S. Food and Drug Administration (FDA) published a discussion paper, “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products.” The paper is a collaboration between FDA’s Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices … Continue Reading

​​​​​​​Cybersecurity in Medical Devices

Photo of Lee H. RosebushPhoto of Lynn SessionsPhoto of Laura MacherelliPhoto of Eric MorrisBy Lee H. Rosebush, Lynn Sessions, Laura Macherelli and Eric Morris on Posted in Alert
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

Staying Ahead of the Curve in Biopharma: Navigating FDA Inspections, Drug Supply Chain Security Act (DSCSA) Implementation, and Supply Chain Disruptions

Photo of Winston S. KirtonPhoto of Lee H. RosebushBy Winston S. Kirton and Lee H. Rosebush on Posted in Podcast
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

FDA Announces Impact of Ending COVID-19 Public Health Emergency

Photo of Winston S. KirtonPhoto of Lee H. RosebushPhoto of Laura MacherelliPhoto of Marc WagnerBy Winston S. Kirton, Lee H. Rosebush, Francis Palumbo, Laura Macherelli and Marc Wagner on Posted in Alert
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

FDA’s Center for Tobacco Products Announces Next Steps to Strengthen Tobacco Program

Photo of Lee H. RosebushPhoto of Lance L. SheaPhoto of Laura MacherelliBy Lee H. Rosebush, Lance L. Shea and Laura Macherelli on Posted in FDA
FDA Commissioner Robert M. Califf, MD, MACC, released a statement on Feb. 24, 2023, announcing next steps the FDA’s CTP plans to take in response to an external evaluation conducted by the Reagan-Udall Foundation. Califf commissioned the external evaluation in September 2022 to analyze the entirety of the Tobacco Program’s operations. The final report contained … Continue Reading

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
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

Discounted Drugs under the 340B Program

Photo of Lee H. RosebushPhoto of Laura MacherelliPhoto of Marc WagnerBy Lee H. Rosebush, Laura Macherelli and Marc Wagner on Posted in Healthcare
The U.S. Court of Appeals for the Third Circuit is currently hearing arguments from pharmaceutical manufacturers Novo Nordisk, Sanofi and AstraZeneca and the Department of Health and Human Services (HHS) on whether the 340B program prohibits pharmaceutical manufacturers from imposing restrictions on how their drugs are distributed. Read the full Alert.… Continue Reading

Note of Caution to Compounding Pharmacies

Photo of Lee H. RosebushPhoto of Winston S. KirtonPhoto of Laura MacherelliPhoto of Marc WagnerBy Lee H. Rosebush, Winston S. Kirton, Laura Macherelli and Marc Wagner on Posted in Alert
Former co-owner of the now defunct New England Compounding Center (NECC) Gregory Conigliaro may face prison time for conspiring to defraud the U.S. Food and Drug Administration (FDA). Prosecutors argued Conigliaro conspired with more than a dozen others at NECC to deceive and defraud the FDA by misrepresenting the facility as solely a compounding pharmacy … Continue Reading

Allergan Win in Medicaid Drug Rebate Statute

Photo of Lee H. RosebushPhoto of Stephen E. RuscusPhoto of Laura MacherelliBy Lee H. Rosebush, Stephen E. Ruscus and Laura Macherelli on Posted in Medicaid
The United States Court of Appeals for the Fourth Circuit decision in US ex rel. Sheldon v. Allergan Sales, LLC, a qui tam False Claims Act (FCA) suit, affirms the complexity of pricing and Medicaid rebates under the Medicaid Drug Rebate Statute, emphasizes the need for government guidance in complex regulations, and further confirms the importance … Continue Reading

Senate Democrats recently introduced the Stop Price Gouging Act

Photo of Lee H. RosebushPhoto of Nicholas C. MowbrayPhoto of Chris JonesBy Lee H. Rosebush, Nicholas C. Mowbray and Chris Jones on Posted in Healthcare
Senate Democrats recently introduced the Stop Price Gouging Act (S. 378), which seeks to place an excise tax on pharmaceutical companies in proportion to price spikes on prescription drugs. The bill generally requires a company to justify to the Department of Health and Human Services (DHHS) any spike in prescription drug prices, but it is … 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

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

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

Vermont to Require Drug Transparency

Photo of Lee H. RosebushBy Lee H. Rosebush and Nita Garg on Posted in Uncategorized
Vermont recently became the first state to require drug manufacturers to provide justification for price increases. Under the new law, data on the cost of the drug will come from the state Medicaid program. The Department of Vermont Health Access (DVHA) and the Green Mountain Care Board (GMCB) will work together to create a yearly … Continue Reading

HHS Reopens Comment Period for Proposed Rule on 340B Drug Program

Photo of Lee H. RosebushBy Lee H. Rosebush and Nita Garg on Posted in Uncategorized
The U.S. Department of Health and Human Services (HHS) is reopening the comment period for the proposed rule titled “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.” HHS released the proposed rule on June 17, 2015, and the original comment period ended August 17, 2015. The 340B Drug Pricing Program requires drug manufacturers … Continue Reading

New Medicare Part B Payment Model is Most Recent Payor Response to Increasing Drug Prices

Photo of Lee H. RosebushBy Lee H. Rosebush and Nita Garg on Posted in Uncategorized
Recent activity by the federal government along with commercial payors may be indicative of further changes to how payors, providers, and pharmaceutical manufacturers engage in prescription drug arrangements. A recently announced proposed rule by CMS would create a new Medicare Part B prescription drug payment model intended to improve quality of care and deliver better value for … Continue Reading

CMS Pitches Controversial Payment Model for Medicare Part B Drugs

Photo of Lee H. RosebushBy Lee H. Rosebush and Nita Garg on Posted in Uncategorized
CMS recently announced a proposed rule that would potentially create a new Medicare Part B prescription drug payment model. The proposed model is intended to improve quality of care and deliver better value for Medicare Part B beneficiaries. However, many providers and drug manufacturers have expressed concern that the new payment model will emphasize cost-cutting measures at … 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

DOJ’s Increased Scrutiny of Pharmaceutical Manufacturer and Specialty Pharmacy Ties

Photo of Lee H. RosebushPhoto of Lindsay HolmesBy Lee H. Rosebush, Lindsay Holmes and David Kardian on Posted in Uncategorized
Over the past two years, the relationship between pharmaceutical manufacturers and specialty pharmacies has been under increased scrutiny by the U.S. Department of Justice (DOJ). Specifically, the DOJ has targeted industry’s use of pharmaceutical providers and specialty pharmacies to enhance drug sales in at least two false claim actions. A third separate matter, in which … Continue Reading

Hello Budget Agreement; Goodbye Provider-Based Status?

Photo of Robert M. WolinPhoto of Lee H. RosebushBy Robert M. Wolin, Susan Feigin Harris and Lee H. Rosebush on Posted in Uncategorized
H.R. 1314, the Bipartisan Budget Act of 2015, was signed into law by President Obama on November 2, 2015. The two-year budget framework, which raises the federal debt limit through March 2017, partially rolls back the Budget Control Act’s discretionary caps by $80 billion above the sequester level for two consecutive years (FY 2016 and … Continue Reading

D.C. District Court Deals Blow to HHS 340B Program Interpretive Rule

Photo of Lee H. RosebushPhoto of Lindsay HolmesBy Lee H. Rosebush and Lindsay Holmes on Posted in Uncategorized
Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the Pharmaceutical Research and Manufacturers of America (PhRMA) in October 2014, was recently vacated in favor of PhRMA by the … Continue Reading

Rosebush and Holmes Author AHLA Connections Cover Story on U.S. Drug Costs and Patient Access Issues

Photo of Lee H. RosebushPhoto of Lindsay HolmesBy Lee H. Rosebush and Lindsay Holmes on Posted in Uncategorized
Partner Lee Rosebush and Associate Lindsay Holmes authored the cover story for the October 2015 issue of the American Health Lawyers Association publication AHLA Connections. In the article, “U.S. Drug Costs and Patient Access Issues in the 21st Century,” they write: High drug costs and concerns regarding patient access to expensive medications are not new. … Continue Reading
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