“Drug shortages are pretty much a daily disaster right now for most hospitals,” reported Pharmacy Times on December 10. Meanwhile, “The US Food and Drug Administration (FDA) is not just seeing an increase in drug shortages but also a spike in the intensity and duration of shortages,” writes Zachary Brennan, summarizing conclusions from an FDA event last month.
This summer FDA Commissioner Scott Gottlieb, MD convened a Drug Shortage Task Force “to seek root causes of drug shortages and potential enduring solutions.”
The Task Force has issued a request for public comment as it prepares a report to Congress, and the deadline to submit solutions is 11:59pm Eastern on January 11. Please help us, your colleagues, and your patients, take advantage of this opportunity to share a few key ideas with the Task Force.
Here’s how you can help!
Step 1: Copy these template comments.
Dear Commissioner Gottlieb and Members of the FDA Drug Shortage Task Force,
Thank you for this opportunity to submit comments on “Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions,” Docket No. FDA-2018-N-3272.
Policies that prioritize the interests of middlemen above patients have fostered an environment unfriendly to competition and innovation and conducive to shortages and high prices.
The FDA should continue progress towards lowering counterproductive barriers that impede innovation and deter the abundant supply of lifesaving care and cures. More streamlined approval processes and “Right to Try” laws are good first steps.
Shortages, unaffordability, and improper steering of patients to the most profitable product, instead of the one that best meets patients’ needs, are driven in part by anti-kickback safe harbors abused by middlemen like Group Purchasing Organizations (GPOs) and Pharmacy Benefits Managers (PBMs). For example, sole-source contracts, facilitated by kickbacks, are an anti-competitive feature of many GPO arrangements with hospitals and manufacturers, which increase the risk of shortages and push prices higher. For details see jpands.org/vol23no2/singleton.pdf and physiciansagainstdrugshortages.com.
The FDA should work to remedy GPO and PBM abuse of safe harbors by encouraging Congress to repeal 42 U.S.C. § 1320a-7b(b)(3)(C) and amplifying HHS-OIG efforts to stop exploitation of 42 C.F.R. § 1001.952(j) and related regulations.
In addition, the FDA should collaborate with other agencies and Congress to address further foundational policy flaws that quash the abundance that results when free market principles are embraced, not ignored.
Thank you for your consideration of the above concerns and reforms. The bottom line is this: it is time to prioritize patients. Doing so means removing regulation blocking their access to care and excising the middlemen who profit without adding value and too often cause harm.
Step 2: Visit the comment submission form, paste in the comments, modify them to your satisfaction, and submit.
The comment submission form is located at:
Thank you for speaking out! Your voice makes a difference.