Prescription Drugs Compliance

News & Analysis as of

EPA'S Hazardous Waste Pharmaceuticals Rules May Impose Significant Burdens on Health Care Facilities - Comment Period Runs Until...

The Environmental Protection Agency (EPA) has promulgated its proposed regulation of “hazardous waste pharmaceuticals,” i.e., pharmaceutical residues discarded from health care facilities which also meet EPA’s long-standing...more

Bristol-Myers Squibb Pays $14 Million to SEC to Resolve China FCPA Offenses

On October 5, the SEC announced a settlement with Bristol-Myers Squibb to resolve allegations that the pharmaceutical company’s Chinese joint venture, BMS China, gave cash, jewelry, and other benefits to health care providers...more

Four Clear Messages from Bristol Meyers Squibb FCPA Enforcement Action

The SEC’s FCPA enforcement action for $14.6 million against Bristol Meyers Squibb (“BMS”) in China provides a textbook example of how things can go wrong in China. For the compliance practitioner (as well as CEO and...more

Bristol-Myers Squibb FCPA Enforcement Action

Yesterday, the Securities and Exchange Commission (SEC) announced a Foreign Corrupt Practices Act (FCPA) enforcement action against Bristol-Myers Squibb Company (BMS) for the actions of the company’s joint venture (JV) in...more

HHS Issues Proposed 340B Program Omnibus Guidance: Five Things to Watch

The 340B Drug Pricing Program (340B Program), established by Section 602 of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA) of HHS. The 340B Program requires...more

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...more

EPA Proposes New Rules for Pharmaceutical Hazardous Waste Management and for Other Hazardous Waste Generators

The U.S. Environmental Protection Agency (EPA) has announced two new proposed hazardous waste rules that EPA believes would clarify and simplify requirements for health care facilities and retail pharmacies to manage their...more

HRSA Issues 340B Program Omnibus Guidance

On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more

HRSA Issues Long-Awaited 340B Program Omnibus Guidance Proposal

After much anticipation, the Health Resources and Services Administration (HRSA) late last week released its 340B Drug Pricing Program Omnibus Guidance Proposal (the Proposal). HRSA indicates that its goal in issuing the...more

New Jersey Rulings Allay Personal Jurisdiction Concerns Raised by Daimler and Goodyear

Two judges in the U.S. District Court for the District of New Jersey have denied motions to dismiss for personal jurisdiction in Hatch-Waxman litigations based on the defendants’ compliance with New Jersey’s foreign...more

FDA Regulatory and Compliance Monthly Recap - September 2014

In This Issue: - FDA sends warning letters to companies that made claims on social media that their products treat, cure Ebola, marking the first time the agency singles out Pinterest - OIG issues special...more

Outrageous Opinions in Registration Statements

In Omnicare, Inc. v. Laborers District Council Construction Industry Pension Fund, No. 13-435, the respondents fired back at the petitioners in a brief filed with the Supreme Court, posing a simple question: “Whether...more

GlaxoSmithKline Fined Again – The Cost of Doing Business?

It is seen as the cost of doing business. It may be illegal, but is also highly profitable, so why stop? That seems to be the attitude of many pharmaceutical companies – and the latest proof of that comes in the form...more

The Case of Ophthalmic Drugs in Italy and France: A Lesson to Learn - Parallel Antitrust Investigations and Cooperation Between...

The recent investigations into two pharmaceutical companies active in the ophthalmic drugs market in Italy and France serve as a reminder of the cooperation that takes place between national competition authorities....more

‘Country of Origin’ Compliance: The Top 10 Things Pharmaceutical Companies Need to Know

What is the “country of origin” for the drugs you manufacture? This question arises every time a pharmaceutical company labels a drug, imports it, exports it, markets it, or sells it to the U.S. government. Unfortunately, the...more

False Claim Act: 2013 Year in Review

Last year continued the trend of robust False Claims Act (FCA) enforcement by the U.S. Department of Justice (DOJ) and proliferating qui tam lawsuits brought by whistleblowers on behalf of the United States. In 2012, DOJ...more

What Hath GSK Wrought? More Compliance Lessons From China

In an article, entitled “GSK China probe flags up wider worries”, in the Wednesday edition of the Financial Times (FT) reporters Andrew Jack and Patti Waldmeir discussed the ongoing bribery and corruption scandal involving...more

Special Edition: Health Law Update: Senate Passes "Drug Quality and Security Act"

On November 18, 2013, the Senate, by voice vote, approved the Drug Quality and Security Act (DQSA), intended to bolster the Food and Drug Administration's (FDA) oversight of compounding pharmacies in light of last year's...more

Health Law Alert - August 2013: New York’s I-STOP Law Goes into Effect for Practitioners – August 27, 2013

A new law, the Internet System for Tracking Over-Prescribing (I-STOP) Law (§3343-a of the NYS Public Health Law) enacted one year ago, will go into effect on August 27, 2013, requiring practitioners who prescribe controlled...more

Healthcare Law -- Aug 19, 2013

As the Healthcare Landscape Shifts, Four Issues Are Critical to Build Effective Market Access Strategies - In this time of high growth and fast change for the healthcare industry, pharmaceutical, biotechnology and...more

340B Drug Pricing Program Update: Hospital Recertification and Recent Audit Activity

As part of its expanded authority resulting from the Patient Protection and Affordable Care Act (PPACA), the Health Resources and Services Administration (HRSA) is continuing its efforts to ensure compliance with 340B Drug...more

CMS Announces Proposed Rule Implementing the ACA's MLR Requirements for MA and Prescription Drug Plans

On February 15, the Centers for Medicare & Medicaid Services (CMS) released its Proposed Rule, effective calendar year (CY) 2014, implementing the Medical Loss Ratio (MLR) requirements for Medicare Advantage (MA)...more

Are the Feds Enlisting FedEx to Police the Illegal Pharma Market?

The government may be coming up with a new cost-effective measure to help balance the federal budget – enlisting private companies to do their policing. A 2011 settlement between the Justice Department and Google for $500...more

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