As Prescribed

Earlier in the summer, the FDA issued a quartet of guidance documents setting forth the Agency’s plan for implementing requirements under the Drug Supply Chain Security Act (DSCSA). The DSCSA directs FDA to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. It also requires that FDA establish national licensure standards for wholesale distributors and third-party logistics providers and establishes requirements for these entities to issue annual reports to FDA. Taken as a whole, these new guidances clarify FDA’s expectations for stakeholders to comply with the law to achieve a safer, more secure, and more trusted drug supply chain.

China’s long-awaited Personal Information Protection Law (PIPL) has potentially significant implications for pharmaceutical and medical device companies doing business in China or with the market in China. Personal health information is considered sensitive personal information and is now subject to enhanced data compliance requirements for collection, processing, and cross-border transfer. After two rounds of draft versions, the PIPL was finally passed by the Standing Committee of the National People's Congress on August 20, 2021 and will become effective November 1, 2021.

A bipartisan group of lawmakers in the US House of Representatives’ Judiciary Antitrust Subcommittee recently voted three bills out of committee that target the pharmaceutical industry practices of so-called “reverse payments,” “product hopping,” and “sham” citizen petitioning. Versions of some of these bills had been under consideration by this subcommittee for years, but had not been voted out of committee until now.