FDA's Mistake: Lawmakers seek solutions

On Tuesday, April 22, 2008, House lawmakers accused the Food and Drug Administration and Baxter International Inc. of failing the American public over heparin.  This came as no surprise since the quickly amplifying heparin controversy raised concerns amongst officials.

In early February, the FDA admitted to violating its own policy by not inspecting the Changzhou SPL plant in China.  Once the agency did inspect the plant, they found many inconsistenciesand in one case found a crude lot “that included material from an unacceptable workshop vendor were used in Heparin Sodium USP marketed to the USA.”

The FDA’s failure to inspect the Chinese plant prior to the contamination sparked questions about the FDA’s policies on foreign inspections.  Senator Chuck Grassley, Ranking Member of the Senate Committee on Finance, launched an investigation in early February regarding the deficiencies at Baxter’s Chinese manufacturing plant, and whether the failure of the FDA to inspect the plant in a timely manner, led to the contamination of heparin.

On February 14th, 2008, Senator Grassley sent letters to the FDA and Baxter, asking for thorough information regarding the FDA’s policies as well as an inspection of the Chinese plant carried out by Baxter.  The Senator’s letter to the FDA stated, “this facility has never been inspected by the FDA.  This comes on the heels of my earlier  inquiry, which raised serious concerns that the FDA inspected only 11 pharmaceutical plants in China during 2007, even though hundreds if not thousands of facilities are producing active pharmaceutical ingredients used in drugs sold in this country.”

FDA Public Health Advisory:
Important Warnings and Instructions for Heparin Sodium Injection (Baxter)

In a more recent statement, given during a hearing held before a House subcommittee on April 22, 2008, Rep. Bart Stupak (D., Mich) reprimanded the FDA saying, “Last year, this nation’s regulatory failures resulted in dead dogs and cats. This year, it has tragically led to the deaths of people.”

The problem, according to lawmakers, is the lack of foreign inspections by the agency.  Rep. John Shimkus (R., Ill) said “We have already heard the numbers that show the imbalance in risk priorities, with most domestic firms inspected about every two years, but literally hundreds of foreign firms that have not seen an inspection, if that at all, in a decade.”

The heparin controversy has only magnified the current situation with foreign drug facilities.  Both Democrat and Republican members of the committee agreed that the lack of foreign inspections is a large problem.  In the last fiscal year, the FDA inspected 30 foreign plants and in this year expects to inspect as much as 50.  The members of congress, however, are not impressed by these numbers since there are more than 3,200 foreign drug firms listed by the agency.

FDA commissioner Andrew von Eschenbach defended the agency saying he had previously asked the administration for more funds to conduct inspections.  He agreed that more foreign inspections are necessary but warned that inspecting every foreign firm every two to three years, like the house suggested, wasn’t the solution to the problem.  “It’s much more complex, and the solution needs to be much more comprehensive than simply inspecting a facility.” said von Eschenbach. 

The FDA plans on establishing foreign offices in China and possibly in India, Latin America, the Middle East and Europe.  Still, it is far too early to determine if these plans will work.

The truth is that the FDA simply lacks the resources to inspect all foreign drug plants. Rep. Joe Barton (R., Texas) computed that in order for foreign firms to be inspected as regularly as domestic firms, the current budget would have to be multiplied by seven, costing the country about $70 million annually.

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