Voting with the majority, 1st District representative, Andy Harris, voted twice with the entire House of Representatives to advance House Bill H.R. 1520 and H.R 1503. The first Bill passed the House with 420 Yeas and 0 Nays. The second Bill passed with 422 Yeas and 0 Nays.
What is House Bill H.R. 1520?
This bill — the Purple Book Continuity Act of 2019 — would require that the FDA proactively determine the reference product exclusivity for each licensed biological product (or biosimilar) listed in the Purple Book. It also would direct the FDA to solicit public comments regarding the type of information that should be contained in the Purple Book and transmit a report to the Congress within three years after the date of enactment.
This bill would also impose a private-sector mandate requiring biological product manufacturers to provide the FDA with certain patent information when that information is shared with biosimilar product manufacturers.
Finally, this bill would specify that the Purple Book should be published to the FDA’s website and updated regularly.
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What is House Bill H.R. 1503?
This bill — the Orange Book Transparency Act of 2019 — would increase access to lower-cost generic drugs and bolster competition within the generic drug marketplace to help reduce drug costs by ensuring that patents listed in the Approved Drug Products with Therapeutic Equivalence Evaluations Publication (aka the Orange Book) are valid and relevant to the approved product. It’d also strengthen requirements surrounding the removal of invalidated patents from the Orange Book.
Specifically, this bill would:
- Clarify the types of patents listed in the Orange Book (and require the removal of invalidated patents);
- Require a list of applicable exclusivities for listed drugs;
- Create a private-sector mandate requiring drug manufacturers to promptly submit a patent withdrawal or removal to the FDA for patents found invalid by the Patent Trial and Appeals Board or another court; and
- Empower the FDA to: 1) add additional patents to the Orange Book if necessary, 2) promptly remove patents from the Orange Book which are found to be invalid, and 3) reconsider the types of patents listed in the Orange Book within one year of enactment.
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Christopher A. Koch