Citing Ohio heparin deaths, Sen. Brown has more questions for FDA on import safety
Ohio Senator Sherrod Brown says he’s disturbed that 80 percent of active pharmaceutical ingredients in U.S. drugs are foreign-made, saying that has allowed drug companies to “skirt existing regulations” and “outsource drug safety standards.”
“Drug company profits cannot come at the expense of consumer safety,” Brown said. He framed his concern around three constituents who died after taking contaminated Heparin imported from China in 2008. The attention on the practical implications of FDA’s ability to protect American patients and consumers is laudable, especially in the midst of anti-regulation fervor on the Hill.
Responding yesterday to the FDA’s recent report on import safety, Brown issued a series of serious follow-up questions and recommendations.
Some of the recommendations, such as exploring import fees to make up the cost difference between domestic and foreign inspections, were discussed at the Pew Health Group’s After Heparin conference in March, a forum where regulators, industry and policymakers gathered to discuss a forthcoming set of recommendations on global drug safety. Brown asks FDA Commissioner Margaret Hamburg her thoughts on import and facility fees, as well as assessing penalties to companies responsible for recalled, counterfeit, or substandard drugs.
Some of Brown’s other suggestions, such as giving FDA authority to deny product entrance to any company that’s turned away inspectors, exist in a House bill introduced earlier this year, the Drug Safety Enhancement Act. (More on the DSEA here!)
We’re glad to see a Congressperson taking up the FDA’s new report so quickly and thoroughly. Brown’s questions to the agency are good ones, and it’s worth highlighting some of them here.
- What steps can your agency take to ensure that key exporters are not only included in the coalitions, but also abide by the resulting comparability and information sharing standards?
- How often are FDA inspectors denied access to foreign pharmaceutical or API facilities either by the company or government officials?
- Does your agency have the authority to refuse entry into the United States of pharmaceutical products or APIs from foreign entities if the FDA has been denied access to manufacturing facilities? If it does not have such authority, is further legislation necessary?
- What role do import refusals from China – and other countries – play in the in the drug shortage crisis in the United States? Specifically, what percentage of drug shortages result from imported refusals as compared to consolidation of pharmaceutical companies, economic decisions of a company to cease production, and problems in manufacturing?
- The report also notes that some countries, including Mexico and Costa Rica, consider the FDA seal of approval equivalent to approval from their respective oversight agencies. What countries does the FDA believe have stringent enough regulations to be equivalent to FDA-approval?
- Which APIs or pharmaceutical products are at the greatest risk for adulteration or counterfeiting?
- Are the pharmaceutical companies that manufacture these products or utilize these APIs aware of these risks and what oversight activities do these companies perform themselves at contracted facilities?
- The report states that the FDA may be unable to fully and completely share data across the coalition due to legal restrictions. What restrictions are currently in place and what sort of legislative change is necessary to facilitate the FDA’s exchange of information with foreign counterparts?
–Kate Petersen, PostScript blogger