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Keeping you afloat amidst the rising sea of regulations

FDA Authorizes First Direct-to-Consumer Genetic Test for Cancer

On March 6, 2018, the US Food and Drug Administration issued an authorization letter to 23andMe, Inc. that permits marketing of the company’s genetic test for use in screening consumers for select BRCA1/BRCA2 breast cancer gene mutations that are most commonly found in people of Ashkenazi (Eastern European) Jewish descent.

Some Things Never Change: Lavish Meals Result in Significant FCA Liability for Device Manufacturer

A recent settlement announced by the US Department of Justice serves as a warning to pharmaceutical and device manufacturers that the government remains concerned about the provision of expensive meals to physicians and the impact such meals may have on a physician’s independent medical judgment.

New CMS System to Report Average Sales Price (ASP) Data for Part B Drugs

A long time coming and after much anticipation and speculation, CMS is about to unveil an electronic reporting system in which manufacturers will report to CMS their quarterly ASP calculations. Manufacturers must begin to use this system to report ASPs for their Medicare Part B eligible drug products beginning with the Q2 2018 reporting, due April 30, 2018. For Q2 2018 only, the data also must be sent using the current manual process, which will be replaced by the electronic system permanently beginning with the Q3 2018 ASP submission.

Patent Office’s Rulebook Update Supports Personalized Medicine Claims

Personalized medicine patent claims have been under assault since the Supreme Court’s Mayo v. Prometheus decision.1 At best, patent owners and applicants with such claims are experiencing mixed results in district court and the Patent Office. And, to date, the Federal Circuit has not issued a precedential decision involving a subject matter eligibility challenge of personalized medicine. However, the Patent Office’s recent update to its Manual of Patent Examining Procedure (MPEP) could signal a turning point for life science companies.

New Jersey Clamps Down on Pharma Interactions with Prescribers

A new administrative rule promulgated and adopted by the Attorney General for the state of New Jersey (the AG) will “regulate the receipt and acceptance by prescribers of anything of value from pharmaceutical manufacturers” in an attempt to ensure that prescriber’s independent medical judgment is not unduly influenced by financial relationships with drug makers.  

Chemical & Life Sciences Patent: Year In Review

This year brought us very significant changes in patent jurisprudence from the Supreme Court and Federal Circuit affecting Chemical & Life Sciences patent practice.

FDA Requires Pharma Companies to Certify Drug Listing Info

In August 2016, the Food and Drug Administration issued a final rule to update and clarify the agency’s drug registration and listing regulations. The rule made some fairly substantial changes even though the rule became effective last November, and drug companies may just now start to feel the impact of some of the rule’s requirements.

Uncertainty Becomes the Norm…for 340B Rulemaking, at Least

On August 21, 2017, the Health Resources and Services Administration (HRSA) published a proposed rule (the Proposed Rule) that would entertain even further delays of the implementation of a January 5, 2017 Final Rule (the Final Rule) regarding calculation of 340B ceiling prices and the imposition of civil monetary

FDA Issues Draft Guidance For Product Identifier Requirements

Last week, the FDA released a draft guidance titled Product Identifier Requirements Under the Drug Supply Chain Security Act--Compliance Policy, with a 60-day comment period ending around September 3, 2017.

Will Opioid Manufacturers Become the Next Big Tobacco?

With the federal response to the opioid crisis still under development, state and local governments continue to file lawsuits against the pharmaceutical companies that manufacturer these products, accusing them of misleading doctors and consumers about the risks of addiction.