Very Brief Blog: The PIE Act (HR 2027): Pre Approval Value Communications with Payers

Section 502 of the FDCA regulates communications before a drug is approved.  It has allowed some health care information to be conveyed to payers, and was expanded by a few phrases in the December 2016 "21st Century Cures Act."   Just weeks later, FDA released a guidance on interpretation of this section that included changes from 21CC (draft guidance here.)

The "Pharmaceutical Information Exchange Act," or PIE Act, was introduced in 2017 and advanced a bit in the legislative cycle in January 2018.  It's strongly supported by AMCP (Association of Managed Care Pharmacists).  They view early economic and value communications as helpful in making more rapid decisions once a drug has been approved.

The revised proposal under PIE is simply a paragraph of text (much of which already is there at 502, having been modified by S. 114 of FDAMA 1997, and then tweaked a bit by 21CC):

“(2) Health care economic information or scientific information provided to a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis carrying out its responsibilities for the selection of drugs for coverage, reimbursement, or other population-based health care management, shall not be considered false or misleading or any other form of misbranding under this paragraph, or a violation of section 505 of this Act or section 351 of the Public Health Service Act, or otherwise prohibited pre-approval promotion of a drug, if it is based on competent and reliable scientific evidence and relates to an investigational new drug or an investigational use of an approved drug. In order for information relating to an investigational use of an approved drug to be provided pursuant to this subparagraph, there must have been submitted to the Secretary a supplemental application for approval of such use, or the study or studies needed to support the submission of a supplemental application for such use must have been completed with the intention that a supplemental application will be submitted to the Secretary for approval of the use. For purposes of this subparagraph, scientific information includes clinical and pre-clinical data and results relating to an unapproved drug therapy, or drug indication, or other condition of use being investigated or developed.”

This section clearly looks to "promotion of a drug" but the corresponding FDA guidance, cited above, is for drugs and devices.

Medicare specifically solicits pre-approval information in a few cases, such as for new technology add-on DRG payments and new HCPCS codes.  In both cases value arguments and data can be submitted to CMS ahead of the FDA approval, and this has been the status quo for quite a few years.