It’s no longer theoretical: The SAFE Drugs Act (HR 6509 / S. 3794)) — the federal bill written by Eli Lilly that would gut the ability of compounders to fill in during drug shortages — may be moving to a mark-up by the Senate Committee on Health, Education, Labor and Pensions. It’s a sign legislators are taking drugmakers’ (false) claims about the bill seriously.
Let’s be clear: If this bill passes, state-licensed pharmacies would be severely restricted in preparing compounded medications for patients even when the manufactured drugs are on the FDA’s shortage list. We’re talking a limit of 20 prescriptions per pharmacy per month for each drug in shortage.
It would do nothing — zilch — to protect patients from fraudulent or experimental drugs, but it would, by design, cripple legitimate pharmacies and outsourcing facilities that serve critical patient needs. Imagine if your sick child needs pediatric amoxycillin suspension, but she’s patient number 21 and the drug is in shortage.
Let’s be clear again: This is not abstract. This is about whether patients can get the medication their physicians say they need when the commercial supply chain fails them.
APC is calling on every member pharmacist to do FOUR THINGS.
Right now:
Then watch your email for two important messages next week:
The bottom line: We need Senate HELP Committee members to hear clearly that gutting shortage drug compounding will not make patients safer — it will leave them with fewer options when commercial drugs are in shortage.
And be sure to come to Compounders on Capitol Hill this September 14–16 to join us in meeting with members of Congress to talk about this (awful) bill and the other major issues facing the compounding profession.