Pharmaceutical & Medical Devices

Pharmaceutical & Medical Devices

The ACA directly impacts several aspects of the pharmaceutical and medical device industry:

  • Notably, the act establishes an abbreviated regulatory pathway for FDA approval of biosimilar products and interchangeable biosimilar products.
  • The Act also includes “Sunshine Provisions,” which (1) require pharmaceutical, medical device, biological, and medical supply manufacturers to report payments made to physicians and teaching hospitals, (2) requires manufacturers and group purchasing organizations to report physician ownership interests in those entities, and (3) requires the Secretary of Health and Human Services to make the this information available on a public database.
On February 15, 2012, the FDA released draft guidance related to the approval of biosimilars. On February 8, 2013, CMS published a final rule offering guidance on implementation of the Sunshine Provisions.  The final rules and modifications and updates to the final rules, as well as further guidance, including Ropes & Gray Analysis, relevant to the pharmaceutical and medical device industry can be found in the resource pages of this topic.

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