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Grassley Turns His 340B Microscope on Manufacturers

Written by: Ellyn L. Sternfield

For the first time, Senator Grassley has turned his scrutiny of the 340B Drug Pricing Program to pharmaceutical manufacturers.

As we previously wrote, Senator Grassley has been among the most vocal of critics in calling for increased oversight of the 340B Drug Pricing Program. Up until now, however, most of Grassley’s criticism has focused on hospitals’ use of 340B drugs and the revenue hospitals derive from expanded use of those drugs.

To date, Grassley’s inquiries and criticism have been focused on hospitals outside of his home state of Iowa. Nevertheless, Iowa hospitals appear to have taken note and have tried to expand the Senator’s areas of focus. An unnamed Iowa hospital complained to Grassley that it was having difficulty obtaining drugs from two manufacturers at the 340B discounted price. Grassley first confirmed with HRSA that the drugs in question should have been available to the hospital through 340B for the stated purposes, and he has now demanded explanations from the two manufacturers as to why the drugs were not made available at 340B discounted prices.

In July, we posted about a concerted effort by safety net hospitals to defend hospitals’ 340B program operations. Coincidentally (or not), the Iowa hospital’s complaints landed on Grassley’s desk on July 17th. We will have to wait and see whether the responses he receives from the manufacturers causes Senator Grassley to modify his calls for changes to and increased oversight of the 340B Drug Pricing Program.

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Theresa C. Carnegie is a Mintz attorney who advises health care clients on a wide array of transactional, regulatory, compliance, fraud and abuse matters, and health law issues. She counsels health plans, pharmacy benefit managers, pharmacies, device manufacturers, and distributors.