WASHINGTON — The Coalition for a Prosperous America (CPA) urged President Joe Biden to address the decades of dereliction of duty by the Food and Drug Administration (FDA) to ensure our nation has a safe, affordable, and readily accessible supply of generic and other essential medicines. Earlier this year, CPA launched Americans for Safe Drugs, a new campaign fighting against foreign generic pharmaceutical manufacturers in China and India that are flagrantly violating the FDA safety regulations, yet still exporting tens of millions of potentially harmful doses of medicine to the U.S.
CPA’s letter outlines how the FDA allows generic drugs to be imported from foreign manufacturers in China and India that have received repeated Warning Letters, which notify manufacturers of significant violations of FDA regulations. Additionally, the letter documents FDA’s failure to address the hundreds of essential medicines that are in shortage, including nearly half of all generic pharmaceuticals on the FDA’s newly created essential medicines list that appear in some form on the FDA’s drug shortage list.
“The FDA is not merely failing, it is worsening the problem of excessive reliance on shoddy foreign manufacturers,” the letter states. “Additionally, FDA does not test imported medicines or inspect the Chinese and Indian plants making them. Recent reports show that imports of generic medicines from foreign manufacturers in India and China are not functioning as they should. For example, absorption rates when examined are off the charts and sometimes nonexistent. Contrary to the understanding of most Americans, the FDA does not even test medicines imported into the U.S. from foreign manufacturers that have received a Warning Letter for significantly violating the agency’s regulations for safety and quality control.”
“The FDA’s lack of inspection, testing and enforcement for foreign drug manufacturers in China and India is a serious problem that is jeopardizing the health of millions of Americans,” the letter continues. “Overseas manufacturers have a long history of evading the bulk of the FDA’s oversight, as the agency’s inspectors have no statutory authority abroad and their ability to inspect facilities is restricted to the level of access that foreign countries and companies are willing to provide.”
“Take for example, Aurobindo, an Indian generic pharmaceutical company. Aurobindo is the largest manufacturer of generics in the world — and the largest volume supplier to the U.S. — because of FDA’s inaction to halt their poor-quality manufacturing practices,” the letter says. “Aurobindo has received multiple Warning Letters and more than a dozen recalls for unsafe or substandard drugs. Instead of blocking importation of Aurobindo’s products and finding alternative suppliers, the FDA has instead continued to reward Aurobindo with countless first generics – the first approval FDA permits which allows for a period of exclusivity in sales.
“This month alone, the FDA cited Aurobindo with six new findings of deviations of good manufacturing practices at their oral manufacturing facility in Hyderabad, India,” the letter documents. “Couple this with past impurity concerns, mold and hair found in drug products, facility leaks that caused contamination, and FDA’s finding this past January that called into question the changing of ingredients for the Active Pharmaceutical Ingredients (API) at their manufacturing facility in India. As one pharmaceutical publication noted, Aurobindo has been repeatedly violating FDA regulations since 2011, yet the FDA has failed to shut down this company or ensure its products being imported to the U.S. are safe and effective.”
Read CPA’s full letter here.
Earlier this year, Americans for Safe Drugs released a public poll of registered voters, conducted by Morning Consult, which shows that Americans overwhelmingly want to stop importing unsafe generic drugs. Key findings from the poll show that:
- 84% of Americans want the FDA to ban imports of generic medicines from foreign manufacturers that have received a Warning Letter.
- 86% of Americans support the FDA testing generic medicines imported into the U.S. from foreign manufacturers that have received a Warning Letter.
- 72% of Americans oppose importing generic medicines from China.
- 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.