Drug Importation in Texas: An Overview
Current status:
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. The agency shared a report about the program in December 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 editors@safemedicines.org and specify your print deadline.
Official actions and statements
- December 1, 2023: Texas Health and Human Services submits its Wholesale Prescription Drug Importation Program Report to the governor and state legislature.
Planning documents
- HB 25: Text | Fiscal Note | Bill Analysis
Background / resources
Just learning about the Texas foreign drug importation proposal? Start with some of these resources that outline the safety issues.
PSM Materials:
Op-eds from the Experts
More than 60,000 Americans died from drug overdoses last year. Fentanyl, a synthetic opioid 100 times more powerful than morphine, caused one-fifth of those fatalities. Local law enforcement and health professionals are working at a feverish pace to prevent fatal overdoses, yet at the same time, some federal lawmakers have proposed legislation that would make it legal to import drugs that are not approved by the Food and Drug Administration into the United States from questionable sources. Such legislation would provide a gateway for international criminal organizations to import counterfeit prescription drugs and deadly illegal opioids, including fentanyl…
Bill McCollum, former attorney general of Florida and member of Congress, wrote about the dangers of drug importation on August 8, 2017:
“Opening the door to increased prescription drug importation will just make it easier for smugglers to ship this dangerous opioid into the United States. For years, we have asked police officers and prosecutors to do more with less. There are few signs that austerity will end. Changing laws to encourage importation of drugs would only add to that burden.”
Terry W. Deese, Peach County, Georgia Sheriff and president of the Georgia Sheriffs’ Association, wrote this editorial for the Macon Telegraph. It was published on July 27, 2017.
“Georgia’s law-enforcement professionals and health officials are scurrying to stop the spread of these harmful pills. But in Washington, Congress may soon make it easier for counterfeit drugs like these — along with illicit prescription medicines — to enter the United States.
This effort doesn’t make any sense. Loosening restrictions on drug importation will worsen the opioid crisis.”
Brandon Macsata, the CEO of the AIDS Drug Assistance Program Advocacy Association, writes about the dangerous unreliability of imported medicines. (Originally published in the The Washington Blade and the ADAP blog.)
The bills before Congress would remove many of the license and oversight requirements on the drugs imported into the United States by lifting those barriers, inviting an influx of bogus pharmaceutical products from the same crime rings that are selling these drugs in other countries around the world that would love better access to the U.S. market.
Law enforcement would inevitably be tasked with policing the problem, at a time when most prosecutors and law enforcement officials have their hands full with the growing opioid crisis. One of the biggest killers is fentanyl, a potent, synthetic opioid pain medication that is being laced into counterfeit pills.
This editorial by Aliyah N. Horton, the executive director of the Maryland Pharmacists Association, was published in the Baltimore Sun on July 19, 2017.
In it, Horton points out the “huge public health risk” posed by buying imported drugs, and urges legislators to vote against unsafe drug importation, and to “seek other avenues to improve patient access, safety and drug affordability.”
In a July 14, 2017 editorial for STAT, Jim Greenwood, the president and CEO of the Biotechnology Innovation Organization (BIO), reminds us that the safety risks of buying prescription medicines from other countries are real:
“The debate about drug importation has been underway for decades. Those who support it have never advanced a responsible plan that would provide the same level of health and safety protections that the FDA has delivered for decades. Its rigorous system of rules and protocols ensure that prescription drugs in this country are safe and effective. It protects those high standards by preventing the sale of imported prescription drugs that are not approved for use in the U.S.”
A few years ago, Maine introduced similar legislation that allowed patients to buy drugs from foreign pharmacies. We, too, wanted to provide patients with lower-cost medicines.
It proved to be a big mistake. Instead of getting drugs from Canada, we got dangerous and ineffective counterfeit pills from other countries. Maine’s disastrous experience with counterfeit Canadian drug imports should serve as a lesson to our lawmakers to say no to drug importation legislation.
The Philadelphia Inquirer published this editorial by George M. Karavetsos, a partner with the global law form DLA Piper, and former director of the U.S. Food and Drug Administration Office of Criminal Investigations.
Proposed Drug Importation Law Will Worsen U.S. Opioid Epidemic
More than 60,000 Americans died from drug overdoses last year. Fentanyl, a synthetic opioid 100 times more powerful than morphine, caused one-fifth of those fatalities. Local law enforcement and health professionals are working at a feverish pace to prevent fatal overdoses. Even librarians in drug-plagued neighborhoods . . .
Investor’s Business Daily published this editorial by D. Wayne Taylor, Executive Director of the Cameron Institute, a not-for-profit, public policy think tank specializing in the independent study of health, social and economic issues both in Canada and around the world.