News & Analysis as of

FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategy (REMS) Determinations

On September 21, 2016, the US Food and Drug Administration (FDA) issued Draft Guidance for Industry: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary, which is intended to clarify how the FDA...more

Senate Judiciary Introduces CREATES Act To Expedite Access To Affordable Drugs

Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of...more

Senators Introduce the CREATES Act

In furtherance of the government’s efforts to bring down healthcare costs, Senators Patrick Leahy (D-VT.), Chuck Grassley (R-IA), Amy Klobuchar (D-MN), and Mike Lee (R-UT) have introduced the Creating and Restoring Equal...more

Four Takeaways from the ABA Antitrust Section's 2016 Spring Meeting

Antitrust practitioners, enforcers and industry professionals came together in Washington, D.C. for the 64th installment of the ABA Section of Antitrust Law's annual Spring Meeting. The Spring Meeting provides a look at the...more

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

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...more

Washington Healthcare Update

This Week: Congress and the administration focus on the opioid addiction epidemic... Override of the president’s veto of legislation that would have repealed the Affordable Care Act fails, to no one’s surprise... Senate...more

Blog: FDA Launches New REMS Website

The U.S. Food and Drug Administration (FDA) launched this week REMS@FDA, a Risk Evaluation and Mitigation Strategy (REMS) database website. The new, user-friendly website contains a table of all currently approved individual...more

REMS and Antitrust: Latest Litigation Lessons

Brand name pharmaceutical companies have long stood in the way of generic pharmaceuticals entering the market. To keep generics at bay, brands have used a variety tactics, including ultimately unlawful ones like fraudulently...more

Healthcare Tops the Agenda of U.S. Antitrust Enforcers

Agencies promise close scrutiny of hospital mergers, reverse payment settlements, and REMS abuses. During a roundtable discussion featuring federal and state enforcers at the American Bar Association Section of...more

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