Today, the FDA published a Proposed Rule (371 pages!) to amend its regulations and to implement Title XI of the Medicare Modernization Act (MMA). FDA is taking this step because it has been regulation directly from the statute since its passage, but also to facilitate compliance with and efficient enforcement of the FD&C Act, and to clarify and update these regulations based on recent court decisions and our practical experience implementing provisions related to the approval of 505(b)(2) applications and ANDAs.
The Proposed Rule addresses revised definitions, the submission of patent information, patent certifications, the notice provisions of paragraph IV certifications, amendments to certifications as well as amendments and supplements to applications, . It also addresses certifications for reissue patents, which was the subject of a recent court decision unfavorable to the FDA.
The Proposed Rule also addresses amendments or supplements to a 505(b)(2) application for a different drug and amendments or supplements to an ANDA that reference a different listed drug. There are sections that describe petitions to change a listed drug, filing an NDA and receiving an ANDA, revisions to the approval and refuse-to-approve regulations, issues covering patents and exclusivity and the approval triggers as well as issues addressing the 45-day clock and conversion of a tentative approval to final approval.
The document also addresses certain bioavailability and bioequivalence requirements including the requirements for products not absorbed or not intended to be absorbed into the blood stream.
There is likely to be a lot of detail that explains how the FDA has been regulating from the statute over these past number of years that will finally be codified. As noted above, the document is 371 pages long and we are just starting to dive into the document (which can be found here). Over the next couple of weeks, we will provide further posts outlining some of what we see as the most significant regulatory issues and provisions..