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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS

Our FDA lawyers discuss provisions in the Coronavirus Aid, Relief, and Economic Security (CARES) Act that are of particular concern and interest for the pharmaceutical, medical device, animal drug, and food industries, as well the potential effects of the stimulus package, in this recent LawFlash.

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US President Donald Trump signed a pair of appropriations bills into law on December 20, including bipartisan legislation intended to facilitate the development of generic and biosimilar products. The bill, previously known as the CREATES Act (H.R. 965/S. 340), allows developers of 505(b)(2) New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) products, as well as biosimilar products, to sue companies holding NDAs or Biological License Applications (BLAs) (each, a License Holder) that refuse to provide “sufficient quantities” of an approved reference drug or biologic on “commercially reasonable, market-based terms.” “Sufficient quantities” are those the developer determines it needs to conduct testing and other regulatory requirements to support an application. “Commercially reasonable, market-based terms” are defined as (1) the nondiscriminatory price at or below the most recent wholesale acquisition cost (WAC) for the product, (2) a delivery schedule that meets the statutorily defined timetable, and (3) no additional conditions on the sale.

A handful of bills that comprised a healthcare reform package championed by Florida House Republicans are on their way to the governor’s desk where they’ll likely be signed into law. The result of an ambitious effort by lawmakers to overhaul how Florida regulates healthcare, the bills represent a striking departure from the current regulatory environment. Passed during the last week of the legislative session with a July 1, 2019, general effective date, providers will want to begin reviewing their policies in anticipation of the coming change.

The New York State Drug Take Back Act (Act), which was signed into law on July 10, 2018, went into effect on January 6, 2019. However, due to statutory timelines, enforcement actions are unlikely to start until after October 2019. Nonetheless, drug manufacturers should continue to diligently work toward the various Act deadlines, as development of a drug take-back program will require an investment of manufacturer time and money.

The proposed Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 could become law in the near future as the Congressional Budget Office reported that the legislation would not increase the budget deficit. The proposed bill would change the oversight of the commercial marketing of OTC drugs by the FDA and authorize the collection and spending of user fees to cover the cost of expediting FDA’s administrative procedures related to OTC products. Both the Senate and the House have proposed versions of the bill that are largely similar with variances mostly in the length of exclusivity. Therefore, manufacturers can reasonably rely on the major provisions of the bill that are not likely to change.  Manufacturers can start preparing for the proposed revisions by organizing their current OTC product portfolios according to the ingredients’ current monograph status and identifying any ingredients that may be at risk for more immediate FDA action that could impact their regulatory marketing status. 

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