Drugs

PhRMA Wants Changes to Platform Tech Designation

David McFarland

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Pharmaceutical Research and Manufacturers of America (PhRMA) says it is concerned that several of the statements and proposals in an FDA draft guidance on the Platform Technology Designation Program lack clarity or are inconsistent with the law. The PhRMA comment letter recommends that FDA:

  • not impose extra-statutory limits on the technologies that could qualify for designation;
  • clarify and define key statutory terms;
  • clarify that the draft’s examples of qualifying technologies are not exhaustive;
  • revise the draft to comport with section 506K(g);
  • clarify the content of platform technology designation requests and process for their review;
  • more fully describe in the guidance the benefits of platform technology designation;
  • clarify the protection of information in designation requests; and
  • expand the draft guidance content on the revocation of designations.

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