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.

I’m not talking about drug re-importation by little old ladies or Internet drug sites. I am talking about the active ingredients found in prescription drugs.

The Wall Street Journal reported (here; subscription may be required) that “About 80% of active ingredients used in drugs sold in the U.S. come from overseas, a figure that has significantly increased in recent years.” But FDA commissioner Dr. Andrew von Eschenbach had to be repeatedly drubbed by Rep. John Dingell of the House Energy and Commerce Oversight and Investigations Subcommittee before he came up with an estimate for how much money the FDA would need to inspect foreign suppliers to the drug industry.

“You presided over this because you do not have the resources to do the job that you need to do,” said Dingell. “How much money do you need to do the job that you are supposed to do?”

Instead of giving Dingell a straight answer, von Eschenbach replied “Mr. Chairman, I would like to have the resources that would enable us to do a systemic overhaul of the entire process, not a figure that’s related to a cost per inspection times the number of facilities.”

That’s von Eschenbach for you. Systematically ineffectual!

“In November, the Government Accountability Office found that the FDA could inspect about 7% of foreign companies annually and on average inspected such facilities at a rate of once every 13 years. The agency is required to inspect domestic companies every two years and to inspect foreign facilities before the agency approves a new drug or medical device made in that facility. However, there’s no requirement for foreign reinspections.” (WSJ, op. cit.)

The “foreign active ingredient” problem already has been more deadly than any counterfeit drug ordered over the Internet. The recent heparin crisis caused an estimated 81 deaths.

Americans cannot wait for von Eschenbach’s long-promised but never delivered “systemic overhaul.” We need an FDA commissioner that is straight-talking and who asks for and receives the funds needed to do the job!

That’s my opinion. What’s yours?