On March 21, 2018, the Food and Drug Administration (FDA) published two guidance documents addressing postmarketing safety reporting requirements (PMSR) for combination products.  The FDA had previously issued a Final Rule on PMSR for combination products on December 20, 2016 (PMSR Final Rule).

By way of background, combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. Because PMSR regulations for medical products in different categories are individualized (for example, PMSR are different for drugs than they are for medical devices and biological products), the two new guidance documents clarify the PMSR requirements that apply when a product is comprised of multiple medical categories. According to the FDA, these documents were issued in an effort to further interpret the Final Rule by ensuring consistent and complete reporting while simultaneously avoiding duplication in reports.
Continue Reading FDA Provides Guidance on Postmarketing Safety Reporting for Combination Products

The U.S. District Court for the District of Connecticut granted a motion for summary judgment in favor of Becton, Dickinson & Co. (BDC), a medical products provider, on the grounds that its contracts with MedPricer.com, Inc. (MedPricer), a company operating an online auction platform, violated the federal Anti-Kickback Statute (AKS), and were therefore unenforceable under Connecticut state law. MedPricer.com, Inc. v. Becton, Dickinson & Co., 2017 U.S. Dist. LEXIS 30854 (Memorandum opinion).

As described in the opinion, MedPricer enters into service agreements with hospitals and other health care providers to host online “auctions” for the sale of medical equipment. The health care provider determines which vendors to invite to the online auction and MedPricer sends invitations to the vendors. In order to participate in the MedPricer auction, a vendor must, among other things, accept the terms of a click-through user agreement. Vendors that accept the terms of the agreement may submit bids to the health care provider in response to requests for quotes. The agreements at issue before the Court required BDC to pay MedPricer a fee of 1.5% of the value of any purchase from the vendor, whether or not the sale occurs during the auction events or afterward.

Continue Reading Federal Court Holds Online Medical Products Auction Contract Violates the AKS