Lee H. Rosebush

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FDA Issues Guidance on Clinical Research with Cannabis

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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?

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

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

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

House Passes Bill to Help Prevent Prescription Drug Abuse

On September 8, 2015, the House of Representatives passed a bill intended to combat prescription drug abuse through the reauthorization of a program that provides federal grants to states for prescription drug monitoring programs (PDMP). The National All Schedule Prescription Electronic Reporting (NASPER) Reauthorization Act, (H.R. 1725), authored by Rep. Edward Whitfield (R-Ky.) and Rep. … Continue Reading

Don’t Flush the Drugs! The EPA is Coming!

The Environmental Protection Agency (EPA) recently issued a pre-publication Proposed Rule (40 C.F.R. part 266, subpart P) regulating the management and disposal of drugs deemed “hazardous waste pharmaceuticals” by healthcare providers. One of the EPA’s principal objectives in promulgating the Proposed Rule is to curtail the environmental impact of pharmaceuticals on lakes and rivers by reducing the … Continue Reading

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

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

340B Guidance: Eight Key Points Covered Entities Should Consider

On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to as “proposed” guidance by HRSA, the Guidance is intended to clarify a multitude of issues for the thousands of registered covered … Continue Reading

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

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
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