FDA Hurts Patients By Authorizing Florida’s Drug Importation Program | Citizens Against Government Waste

FDA Hurts Patients By Authorizing Florida’s Drug Importation Program

The WasteWatcher

Despite consistent statements for more than 20 years that it is not possible for the Food and Drug Administration (FDA) to guarantee the safety of drugs imported from other countries, the agency approved Florida’s Agency for Health Care Administration’s drug importation program.  The January 5, 2024, approval of this program will allow the state to import certain prescription drugs from Canada. 

The goal of Florida’s program is to lower drug prices for patients.  But their band-aid solution will not only fail to lower the cost of prescription drugs but also stifle innovation and development of new drugs.

The U.S. is the global leader in biopharmaceutical research and development.  The drug importation program threatens this status.  The importation of drugs from other countries will also import their socialist healthcare policies and allow foreign drug markets already subsidized by U.S. research and development investments to resell cheaper and unregulated drugs.  The FDA estimated that nearly 99.1 percent of drug products entering the U.S. through international mail in 2019 were non-compliant with agency standards, and 10 percent of medicines worldwide are estimated to be counterfeit.  Drug importation opens the floodgates to unregulated drugs, which puts patients at risk. 

As Citizens Against Government Waste (CAGW) noted in its March 5, 2020, comments to the FDA on its proposed rule for importation of prescription drugs, the FDA had refused since 2000 to certify the safety of imported drugs.  President Bill Clinton’s Secretary of Health and Human Services Donna Shalala stated in December 2000 that it was “impossible for me to demonstrate that it is safe and cost-effective” to import drugs from foreign countries.  In his November 17, 2015, testimony at the Senate Committee on Health, Education, Labor and Pensions hearing on his nomination, FDA Commissioner Robert Califf (stated that importation would undermine the “closed drug distribution system in the United States” and make “it easier for unapproved drugs, which may include counterfeit or other substandard drugs, to reach American patients putting their treatment at risk.”  He said, “the risks of unapproved products from foreign sources outweigh any potential cost savings.” 

CAGW’s July 19, 2019 letter to the Department of Health and Human Services expressed strong opposition to the department’s drug importation proposal, which would have created two pathways to allow for the “safe” importation of drugs from other countries.  If this proposal had been adopted, it would have allowed states, wholesalers, or pharmacists to develop pilot projects to facilitate the importation of certain medications from Canada.  The proposal would also have permitted drug manufacturers to reroute certain versions of drugs approved by the FDA, which were originally sold in foreign markets, back into the U.S. at a lower price.  The letter noted that no FDA commissioner or HHS secretary had ever determined that importing drugs would prevent the flood of dangerous counterfeit drugs that are causing tens of thousands of deaths across the country.  The Canadian government has repeatedly made it clear that the country has no interest in supplying the U.S. with their drugs, citing concerns over shortages. 

CAGW understands the concern over high drug costs, but competition and innovation drive down costs, not price controls.  The U.S. leads the world in pharmaceutical research and development precisely because it has not adopted a socialistic healthcare system that uses price controls to keep down costs.

Instead of pursuing the ineffective and potentially dangerous importation of drugs, Congress should increase free market incentives and competition in public-sector drug benefit plans, speed up generic drug approvals, modernize clinical trial designs to encourage competition, and write better trade deals to ensure foreign countries pay a fair share of U.S.-funded biopharmaceutical research and development, rather than free-riding on our discoveries.  That would that not only help U.S. consumers, but also increase the respect for innovation and property rights that is needed to encourage more research and development in other countries that would benefit everyone’s health and economic welfare.