Feed the starving FDA
By Allan Coukell on April 25, 2008 – 9:34 am
Members of the Senate HELP Committee yesterday called for more resources for the FDA to protect Americans from unsafe products.
The hearing was a response to the Baxter/heparin debacle.
The BNA (subscription required) reports that Senator Kennedy, the committee chair, said that
drug companies should be required to know more about the suppliers from which they obtain their ingredients and use better tests to detect impurities and contaminants, he said. “FDA obviously needs greater authority and significant additional resources to enforce these requirements, especially with respect to ingredients manufactured overseas.”
Senator Sherrod Brown (D-OH) called for more oversight of imported medical devices too.
But ranking member Senator Michael Enzi (R-WY) said “we cannot inspect our way to safety.” He called for closer cooperation between industry, stakeholders and the FDA.
It was the Elixir Sulfanilamide disaster of 1937 that led to the passage of the Food, Drug and Cosmetic Act, which first required Agency oversight of safety tests. Nothing since suggests that the industry is likely to solve this problem without a strong push from government.
Posted in Drug ingredients, FDA |
One Comment to “Feed the starving FDA”
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April 28th, 2008 at 9:07 am
It’s in everybody’s interest to create one federal requirement rather than competing state requirements. But I worry that we’ll end up legislating onerous pedigree requirements that will cost a lot of money for the good guys, while letting the bad guys slip right through. Protecting the package isn’t enough: protected packages end up with counterfeit product inside. That’s why InfraTrac concentrates on authenticating product: even if a link in the pedigree chain is missing or corrupt, you can still verify the quality of the product.