What’s next for compounding?

Dec. 19, 2016
The American Academy of Dermatology Association (AADA) recently joined 16 organizations representing physicians, patient advocates, pharmacists and other health care providers in sending a letter to the transition team of President-elect Donald Trump regarding patients’ access to compounded medications. This comes as the U.S. Food and Drug Administration (FDA) considers finalizing compounding guidance documents which could limit compounding where the drug is considered a copy of a drug that is commercially available.

The letter expresses concern about the FDA’s implementation of the Drug Quality and Security Act (DQSA). It reads: “During a time of rising drug prices and increasing shortages, it is paramount that patient access be preserved for compounded medications. We are concerned that the FDA is implementing the DQSA in a way that is negatively impacting patient access to medications and subjecting state-licensed compounding pharmacies to FDA oversight and manufacturer standards in a way that exceeds the authority given to the Agency by Congress.”

In addition to asking that the new Administration consider rescinding these guidance documents, should the FDA proceed with finalizing them, the letter also offers ongoing assistance on these important issues to the transition team and the Trump Administration’s still-forming health policy team.

It is not clear where President-elect Trump stands on the FDA’s draft compounding guidance. Click here to read more about the guidance documents and learn how you can voice opposition to these restrictions.