Letter to Andrew von Eschenbach, Commissioner of the FDA, Re: Information About Foreign Inspections, Drug Safety

Letter

Letter to Andrew von Eschenbach, Commissioner of the FDA, Re: Information About Foreign Inspections, Drug Safety

GRASSLEY PRESSES FDA FOR MORE INFORMATION ABOUT FOREIGN INSPECTIONS, DRUG SAFETY

Senator Chuck Grassley has sent another letter to the Food and Drug Administration about its program for inspecting overseas facilities that manufacture pharmaceutical drug components.

Grassley's new questions cover a range of issues, including the drug-safety agency's reliance on translators provided by the manufacturing plants during foreign inspections; responsibilities within foreign chains of production; the identity of the plant that had been confused with the Chinese manufacturing plant that made an ingredient in the blood thinner heparin; and other drugs on the market that may contain ingredients also manufactured by the Chinese plant in question.

Earlier this month, production of heparin was suspended by its manufacturer due to concerns that deficiencies at a Chinese manufacturing plant where the active ingredient in heparin was made may have contributed to the adverse reactions in hundreds of U.S. consumers using the drug.

Grassley previously has asked the Food and Drug Administration about its targeting of agency resources for inspections of pharmaceutical plants around the world, expressing concern about the majority of inspections taking place where a minority of drugs and drug ingredients are manufactured.

The text of all of his letters on the foreign inspection system for pharmaceutical drugs follows here.

February 28, 2008

Andrew C. von Eschenbach, M.D.
Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Commissioner von Eschenbach:

As Ranking Member of the Committee on Finance (Committee), I have a responsibility to the more than 80 million Americans who receive health care coverage under the Medicare and Medicaid programs to oversee the proper administration of these programs and ensure that taxpayer and beneficiary dollars are appropriately spent on safe and effective drugs and devices.

In December, officials from the Food and Drug Administration (FDA/Agency) briefed my staff regarding FDA's program for inspecting foreign pharmaceutical manufacturing plants and ongoing questions regarding inspection funding, emerging exporters, and weaknesses in the inspection process, among other things. During that briefing, FDA officials noted that although there are some employees who can speak a foreign language, they are not necessarily part of the inspection teams. Therefore, FDA sometimes relies on translators provided by the facility to be inspected. I find this problematic because, among other things, relying on translators provided by the facility under inspection creates an apparent conflict of interest, which in turn raises questions about the accuracy, independence, and thoroughness of FDA's inspection of that facility.

Accordingly, please respond to the following questions:

It is my understanding that the FDA does not have designated employees who act as translators during foreign inspections. Given our country's increasing reliance on foreign facilities to produce the active pharmaceutical ingredients (API) that are used in the drugs sold on the U.S. market, it is troubling that the FDA does not ensure that independent translators are part of its inspection teams when there is a need for a translator. Since the FDA does not always have access to its own translators, what systems, if any, does FDA have in place to ensure that the Agency is receiving truthful, accurate, and independent information from the translators provided by the inspected facilities? Has or would the FDA consider employing independent contractors to assist with translations during its foreign inspections?

In FDA's December 12, 2007 response, the Agency provided the Committee with the number of inspections conducted by country in fiscal years 2002-2007. Please identify all of the facilities that were inspected in China, India, Brazil, Saudi Arabia, and Thailand during that time period. For each inspection, please specify whether a translator was required for the inspection. Please also specify whether the translator was an FDA employee, an independent contractor, or an individual provided by the inspected facility.

In my letter dated February 14, 2008, I asked the FDA to respond to several questions regarding its failure to inspect a Chinese facility prior to approval of Baxter's application for heparin. Please also provide a response to the following questions:

Since my Feb. 14 letter, I have learned that Changzhou SPL Co. is the Chinese facility that was supposed to be inspected by the FDA prior to regulatory action on Baxter International Inc.'s (Baxter) application. Was Baxter informed that Changzhou SPL Co. had been previously inspected and therefore did not have to be inspected again? If so, when and how was Baxter informed?

Was Scientific Protein Laboratories LLC, the Wisconsin company that supplied Baxter the active ingredient in heparin through Changzhou SPL Co., informed that the facility had been previously inspected? If not, why not? If so, what duty did Scientific Protein Laboratories LLC have to inform Baxter and/or the FDA that the Chinese facility had never been inspected? Whose responsibility is it to ensure the quality of the API imported into this country?

Does Changzhou SPL Co. produce API used in other drugs that are sold on the U.S. market? If so, please identify these API and the companies that are buying them either directly or indirectly from Changzhou SPL. Is the FDA also investigating the quality of these ingredients?

Please provide the name and location of the facility that was mistaken for Changzhou SPL Co. and specify when this facility was last inspected and what drugs and/or API are produced at this facility.

In addition, I request that the FDA brief my staff regarding its findings from the inspection of Changzhou SPL Co. as soon as possible after the inspection is completed.

Thank you for your cooperation and attention to this important matter. Please respond to the questions and requests set forth in this letter by no later than March 14, 2008.

Sincerely,

Charles E. Grassley
United States Senator
Ranking Member of the Committee on Finance

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