Drug Importation in Texas: An Overview
The Texas Legislature introduced House Bill 25, the Wholesale Prescription Drug Importation Act, in November 2022. PSM shared an analysis of the bill with the Texas House committee that you can read. The bill which has been signed by the Governor, will require the executive commissioner of Texas's Health and Human Services Commission to take action to establish Canadian drug importation beginning in September 2023.
Synopsis / Media Contact
H.B. 25 requires Texas’ Health and Human Services Commission to design a program for bulk importing prescription medicines under 21 USC 384 of the U.S. Food, Drug, and Cosmetics Act, more commonly known as a Section 804 State Importation Program (SIP).
For over two decades these programs have proven to be impossible to build safely because:
- Canada refuses to release bulk medications to these programs and has taken steps to restrict U.S. access to their drug supply;
- Canada does not have a Track and Trace program;
- The cost of testing imported medication far outweighs the savings; and
- Medicaid programs already get medicine cheaper than Canadian provinces, reducing any potential savings.
This legislation has been pushed without concern for the consequences. As many states discovered during the pandemic trying to buy hard-to-find N95 masks, buying medical products that aren't readily available creates great risk of counterfeit products. PSM believes that the Texas legislature is forcing it's patients and pharmacists to take unacceptable risks with patient health and pharmacist liability by enacting this program without looking at the risks.
PSM Executive Director Shabbir Imber Safdar is available to do interviews to explain the risks of this program to media. Contact him through firstname.lastname@example.org and specify your print deadline.
Op-eds from the Experts
Tom Kubic—an FBI veteran, former president and CEO of the Pharmaceutical Security Institute, and president of PSM’s governing board—has the experience to know that the risks of drug importation are “unacceptably high” and the potential rewards are “virtually nil.”
So, what does all of this have to do with importing drugs from a friendly nation like Canada? The simple, inarguable fact is that, once we open up our drug supply, we can no longer ensure the safety of the products in it.
Instead of wasting time and money on dangerous and faulty importation proposals, Congress should encourage the FDA to speed up the drug approval process and reduce the cost of program and application fees for future drug development. In 2022, the application fee for a human drug application will cost $1.6 million for drugs that don’t require clinical data and $3.1 million for medicines that do need clinical data.
In this February 24, 2022 editorial published on the Connecticut Business & Industry Association’s website, Paul Pescatello reviews the practical reasons that mean that importing drugs from Canada will not lower prescription drug prices. Pescatello is the executive director of CBIA’s Bioscience Growth Council and chair of We Work for Health Connecticut.
ADAP Advocacy Association CEO Brandon M. Macsata wrote this editorial, which appeared on the AIDS Drug Assistance Program’s website on April 1, 2021.
The Association first warned constituents that counterfeit Symtuza had been distributed to three U.S. pharmacies in December 2020, when Janssen issued an alert.
This editorial by the Sun Sentinel Editorial Board was published in The Sun Sentinel on December 9, 2020. The Editorial Board consists of Editorial Page Editor Rosemary O’Hara, Dan Sweeney, Steve Bousquet and Editor-in-Chief Julie Anderson. There Go Those Cheaper Drugs. Remember Florida’s plan to save money by importing prescription drugs in bulk from…
This editorial by Joyce Nelson appeared in Counter Punch on December 4, 2020. Nelson is a researcher and writer whose work appears in a wide range of magazines, newspapers and websites.
This editorial, written by Earl D. Fowlkes Jr., appeared in the Washington Blade on December 4, 2020. Fowlkes is the president and CEO of the Center for Black Equity.
In this editorial, which was posted on December 2, 2020, Citizens Against Government Waste decries the expense and futility drug importation.
In this October 23, 2020 editorial, which was published in the The American Journal of Managed Care, Michael Abrams explains why drug importation will not save patients money. Abrams is the co-founder and managing partner of Numerof & Associates.