The Food and Drug Administration (FDA) has come under a great deal of scrutiny for its handling of food safety, medical device review and drug approval. Although the FDA’s job is to regulate these industries, some Congressmen have said that its relationship with the drug industry is too cozy and inappropriate.

What does the FDA do?

According to its website, www.fda.org/, the FDA is a federal agency that is, “responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. FDA also ensures that these products are honestly, accurately and informatively represented to the public.” Most would read that statement as being consumer friendly. However…

Critics say FDA caters to drug companies

Two Congressmen have recently criticized the FDA for paying more attention to the needs of the pharmaceutical industry than to the needs of the public.

Congressman Maurice Hinchey.

Congressman Maurice Hinchey (D-NY), a member of the House Appropriations Subcommittee on Agriculture, pointed out that the FDA met with representatives from the drug industry 112 times, but only had 5 meetings with consumer and patient groups over a 14 month period. In a press release, he said:

The FDA has essentially become the government affairs office of the pharmaceutical industry. The data surrounding . . . FDA's meetings . . . make it more clear than ever that the agency and drug industry continue to have a relationship that is far too cozy and inappropriate. By treating the drug industry like a privileged client that deserves preferential treatment rather than a regulated industry, the FDA is jeopardizing the health and safety of the American public. (Source: www.house.gov/list/speech/mi01_stupak/FDAdrugindustry061107.html)

Congressman Bart Stupak.

Congressman Bart Stupak (D-MI), Chairperson of the Oversight and Investigations Subcommittee of the House of Representative’s Energy and Commerce panel (which oversees the FDA), said that the FDA does not do enough to make sure that drugs are safe and has called for the FDA Commissioner, Andrew von Eschenback to step down.

Stupak has said that he is probing into the FDA’s handling of several drug and medical device issues – one being Heparin, a prescription injectable blood coagulant often used in hemodialysis (the filtering of blood) and cardiac invasive procedures. The FDA admitted that it did not inspect the Chinese plant that provides Baxter Healthcare Corporation with Heparin’s active ingredient – an enzyme taken from pig intestines – which has been linked to several adverse reactions to the drug.

According to a recent article in the Wall Street Journal, Stupak had asked the FDA for briefings on the Heparin debacle, but was told that the briefings could not be scheduled because “they’re too busy.” Stupak believes that drug companies know that the FDA can’t do its job and are taking advantage. He recently told the Los Angeles Times:

The drug companies know that this administration ... will do nothing to them. There is no fear of the FDA. With this culture with laissez faire oversight and regulation, I think they should be gone. If we get rid of them, it will put the drug companies on notice.

If you’ve been injured due to a dangerous drug, medical device or unsafe food product, it’s important to know that you may have recourse against the manufacturer. To contact a qualified attorney whose practice focuses in these areas of law, please click here.