Urgent Need for Policies to Boost Domestic Pharmaceutical Production
WASHINGTON — Americans for Safe Drugs today released a statement highlighting the need to increase domestic pharmaceutical production in light of the current shortage of amoxicillin in the United States that appears to be linked to a surge in Respiratory syncytial virus (RSV) infections. Although the antibiotic does not treat the viruses like RSV infections, it is often prescribed to treat secondary bacterial infections. The Food and Drug Administration (FDA) warned Friday that supplies of amoxicillin oral solution, a critical antibiotic that is typically used to treat infections in children, are currently in shortage. Although the FDA has said it is working with manufacturers to evaluate the supply chain to help prevent or reduce the effects of drug shortages, the agency has done little to boost domestic sourcing of critical pharmaceutical products.
The United States has become heavily dependent on foreign drug manufacturers —particularly in China and India—for essential, lifesaving generic medicines. This is the result of heavily subsidized overseas drug producers artificially lowering their prices to put many U.S. pharmaceutical companies out of business. As a result, the United States is now reliant on imports for at least two-thirds of its generic drug needs. And nearly 90 percent of the active pharmaceutical ingredients that the U.S. needs to manufacture medications are also produced overseas.
The FDA’s lack of enforcement of regulations—especially for foreign drug manufacturers in China and India—has created a multibillion-dollar regulatory loophole for overseas manufacturers that undermines the agency’s ability to protect the American people. The FDA’s uneven enforcement of its regulations incentivizes companies to shift production to countries beyond the reach of the FDA’s more rigorous inspections. The consequence is less resilient pharmaceutical supply chains, shortages of critical products, and more American people exposed to potentially substandard, harmful, and even lethal generic drugs.
According to Morning Consult, 85% of Americans think it’s an important priority—with 43% saying it should be the top priority—for the U.S. government to establish the U.S. as a leader in the generic pharmaceutical manufacturing industry.
“Shortages of critical pharmaceutical products like amoxicillin highlight America’s dangerous reliance on foreign manufacturers for generic drugs,” said Nick Iacovella, spokesman for Americans for Safe Drugs. “It is time for the FDA to return to its mission of ensuring that Americans have a reliable supply of safe, effective, and affordable drugs. That starts with treating foreign drug manufacturers the same as American ones, and taking steps to boost domestic sourcing of critical medicines like antibiotics. Additionally, Congress must increase its oversight over the FDA and take action to boost domestic pharmaceutical production. Our nation’s over-dependence on foreign production has left America deeply vulnerable—a threat that must be addressed before another health crisis puts more American lives at risk.”
We are a group of doctors, patients, health care industry experts, and advocates fighting to ensure all generic medicines are safe, affordable, and always available. Unsafe generic drugs from foreign manufacturers in China and India have been sold in the U.S that have been contaminated with carcinogens and fake ingredients, fall apart when tested, and don’t work as they should. We are fighting back to ensure all generic medicines are safe, affordable, and always available. We want every American to be able to trust the generics they take—every pill, every vial, every time.