Preserving Patient Access to Compounded Medications Act of 2017

Preserving Patient Access to Compounded Medications Act of 2017

This REPRESENTS our last and best chance to reverse the FDA trend to restrict access to compounded medications.

FDA wants to restrict access to compounded medications by:

  • Eliminating Office-Use compounding (FDA has already done this)
  • Restrict pharmacists from using the dietary supplement monographs of the United States Pharmacopoeia (FDA has already done this)
  • Forbid pharmacies from shipping up to 95% of all prescriptions received from out-of-state physicians (FDA has a draft guidance that proclaims FDA will do this)

This is not what Congress intended when they passed the Drug Quality and Security Act (DQSA) Section 503A in 2013.

FDA has recently received multiple letters from Congress asking the FDA to conform to the Congressional intent of Section 503A.  There was hope, with a new FDA commissioner, that the FDA would start to revise some of the 21 Draft Guidances and 10 Final Guidances that have been issued restrict compounding pharmacy.

The Director of FDA in a recent letter to Congress told Congress their interpretation of Section 503A is wrong and FDA’s interpretation is correct.  “FDA does not agree the policies of this guidance deviate from Congressional intent.”[i]  Also, in a June 26th policy statement, FDA Commissioner Scott Gottlieb did not mention a policy change to conform to the law as Congress intended.[ii]

Congress, instead of asking the FDA to comply with Congressional intent, is now in a position to FORCE FDA to comply in the form of a Congressional Bill.
 
H.R.2871 - Preserving Patient Access to Compounded Medications Act of 2017[iii]

This bill will amend the Federal Food, Drug, and Cosmetic Act with respect to compounding pharmacies and for other purposes in the following manner:

  • Allow for Office-Use compounding when authorized by state law (prior to DQSA 503A enactment 36 states allowed for Office-Use dispensing or administration by physicians)
  • Allow pharmacists to use United States Pharmacopoeia dietary supplement monographs (This will allow physicians a larger formulary of compounded medications to order from)
  • Allow unrestricted dispensing of patient prescriptions across state lines (current FDA Guidance indicates only 5% or 30% of compounded drugs to cross state lines)
  • Restrict FDA inspection scope from obtaining financial data, sales data other than shipment data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to this chapter) (does not restrict FDA from inspections related to facilities, product quality, environmental conditions, employee qualifications, etc. of compounding pharmacies)
  • Excludes compounding pharmacies from annual registration with FDA as a manufacturer

This is what you can do to support Congress enforce the rule of law on FDA.

H.R.2871 - Preserving Patient Access to Compounded Medications Act of 2017 is currently referred to the Subcommittee on Health Action by: House Energy and Commerce.

This committee will vote to move the bill from committee to the house floor for a general vote.  We must send an email to each committee member and urge them to vote yes to move the bill to the house floor.

Please ask your Congressman to Co-Sponsor the Griffith/Cuellar “H.R.2871 - Preserving Patient Access to Compounded Medications Act of 2017.”  This bipartisan legislation, introduced by Representative Morgan Griffith (R-VA) and Representative Henry Cuellar (D-TX), will codify Congressional intent into law.

Ask your Senators to support the introduction of a Senate Companion Bill to the Griffith/Cuellar House legislation H.R.2871 - Preserving Patient Access to Compounded Medications Act of 2017.

How you can (quickly) show your grassroots support for this legislation.

You, our physicians and patients, sent over 6,300 letters and emails to Congress through our website to apply pressure to Congress to act.  Thanks to you 65 members of Congress signed the most recent letter asking FDA to change its harmful ways.

You can now support H.R. 2871 to become law that will FORCE FDA to comply.


[i] VIDEO Full Committee Markup: FY18 Agriculture & Energy and Water Appropriations Bills.  Debate on Compounding Amendment to FY 18 budget
https://www.youtube.com/watch?v=tZhPTYtAkUo&feature=youtu.be&t=1h53m24shttps://www.youtube.com/watch?v=tZhPTYtAkUo&feature=youtu.be&t=1h53m24s

[ii] Statement from FDA Commissioner Scott Gottlieb, on the importance of the Drug Quality and Security Act and overseeing the safety of compounded drugs.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm564681.htm

[iii] Text to H.R.2871 - Preserving Patient Access to Compounded Medications Act of 2017
https://www.congress.gov/bill/115th-congress/house-bill/2871/text?format=txt



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