Healthcare on the Hill - Pharmaceutical Information Exchange (PIE) Act

One bill generating some debate on the healthcare front is H.R. 2026 Pharmaceutical Information Exchange Act. The Bill would amend the Federal Food Drug and Cosmetic Act to allow “information about a new investigational medication or the investigational use of a medication approved by the Food and Drug Administration to be provided to health care entities if the information is based on reliable scientific evidence.” It is the second part that is cause for either celebration or concern depending on your position.

The bill was introduced by U.S. Representative Brett Guthrie, R-KY. In each of Representative Guthrie's most recent campaigns (including 2018), the top two industry categories of contributors have been Health Professionals and Pharmaceuticals/Health Products.

While most people agree that physicians should be able to prescribe drugs for any indication they see fit – regardless of whether or not the drug is approved for the condition, there are reasonable restrictions on allowing drug companies to promote drugs for off-label uses. The profit motive at all levels, from corporate down to the reps in the field, can lead to promoting drugs for improper (not just unapproved) use. Anyone who has spent much time as a rep has knows there are some reps who will promote off-label with only scant anecdotal information from a physician or two that a drug can be effective for a non-approved use.

The dangers of using drugs for unapproved use are real. A recent study in Canada found that patients taking drugs for unapproved use were 54 percent more likely to suffer adverse reactions requiring cessation of usage compared with patients taking medications for approved uses. Additionally we all suffer in the form of more expensive healthcare and taxes when drugs are used ineffectively. It is the concerns about possible patient harm and increased costs that have lead a number of public interest groups to oppose the bill.

However, when there is enough evidence that a drug can be effective in treating a condition for which it is not approved, there is no doubt that patients can receive tremendous benefit from the dissemination of that evidence. The difficulty will lie in determining when there is sufficient information and data to justify dissemination and how to make sure that it is disseminated in a responsible manner.

It is interesting to note that the Academy of Managed Care Pharmacy issued a press release on January 17, 2018 praising the U.S. House Energy and Commerce Committee's Subcommittee on Health for its approval of the bill so that it can now go before the full Committee for consideration. Pharmacists in managed care settings are usually very concerned with balancing the sometimes competing interests of controlling costs and improving/protecting patient health and well-being.

The bill will be one to keep an eye on. Similar legislation has been rejected in the past, but there is a lot of interest in clarifying how information about unapproved uses of pharmaceuticals can be promoted to healthcare professionals.

The full text of the bill is below:

H. R. 2026

To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between bio manufacturers and population health decision makers.


April 6, 2017

Mr. Guthrie introduced the following bill; which was referred to the Committee on Energy and Commerce


To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between bio manufacturers and population health decision makers.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,


This Act may be cited as the “ Information Exchange Act”.


Section 502(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(a)) is amended—

(1) by redesignating subparagraph (2) as subparagraph (3);

(2) by inserting after subparagraph (1) the following:

(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.”; and

(3) in subparagraph (3), as redesignated—

(A) by striking “(A)”; and

(B) by striking clause (B).

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