The Heparin Disaster

Monday, April 27, 2009

Grassley, Kennedy Introduce Bill to Protect Against Contaminated Imported Drugs

Sens. Chuck Grassley (R-Iowa) and Edward Kennedy (D-Mass.) introduced new legislation in Congress last week that would broaden the FDA’s inspection and enforcement authority with respect to foreign drugs and medical devices. To view the press release on the proposed legislation, click here.

This legislation, referred to as “The Drug and Device Accountability Act of 2009,” would give the FDA money to conduct foreign drug plant inspections. As stated by Sen. Grassley, “An increasing number of drugs and ingredients for pharmaceuticals are being manufactured in other countries, yet studies show the FDA doesn’t know how many foreign plants are subject to inspection, and the FDA conducts relatively few foreign inspections each year. Our legislation is a practical solution to beefing up the FDA’s inspection work, both domestically and abroad, and holding the FDA accountable for its review of medical devices, where questions have been raised about the agency’s work.”

The proposed legislation would also give the FDA the power to detain products from foreign plants when inspectors believe that a drug, (such as the dirty Chinese heparin that recently killed hundreds of Americans), has been adulterated. This is important because the FDA currently has no alternative, but to rely on the overworked and unfunded U.S. Customs to handle the actual seizure of suspect imported goods.

The bill would also give the FDA the power to issue subpoenas allowing the agency to obtain internal business records from careless drug manufacturers who ship production of their drugs overseas in order to increase corporate profit and avoid regulation meant to protect the American public. As discussed previously in our May 21, 2008 blog, “FDA Needs Subpoena Power,” without this ability, the agency is powerless to obtain internal business records from a negligent company who has allowed contaminated drugs to be sold, (such as Baxter who sold the dirty Chinese heparin from a foreign plant that Baxter knew had never been inspected by the FDA or any other governmental agency).

The FDA is one of the few Federal agencies that currently lacks subpoena power. As previously noted by Rep. Bart Stupak, (Chairman of the investigations panel of the House Commerce Committee), in a letter last year to the former FDA Chief, “An integral part of ensuring the FDA can protect the American people is equipping the Agency with proper resources and enforcement authority it currently lacks….In some cases, the FDA does no testing of its own, and in making decisions it must rely entirely on the test results submitted by manufacturers. Without subpoena power, the only way the FDA can ensure it has the information it needs it to threaten criminal prosecution by the Justice Department if it finds critical data is withheld.”

Finally, the proposed legislation would also require certification of applications for drugs and devices needing FDA approval and establish civil and criminal penalties for false or misleading certifications.

To fund the new powers, the bill would levy fees on plant inspections, thus putting the cost on the drug manufacturers who decide to send production overseas.

This regulation would likely have prevented the Heparin debacle and saved the lives of hundreds of innocent Americans. As such, we commend and support this important legislation.

Labels: Baxter, Baxter Heparin, China, Chinese, Chinese heparin, FDA, Grassley, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, Kennedy, OSCS, Stupak

posted by Pamela A. Borgess # 10:13 AM 0 Comments

Tuesday, August 12, 2008

Important Anti-Preemption Bill Introduced by Senators Kennedy and Leahy

Sens. Edward Kennedy (D-Mass.) and Patrick Leahy (D-Vt.) have followed the lead of House lawmakers and introduced a Senate counterpart of the Medical Device Safety Act of 2008 to ensure individuals are not prevented from seeking legal recourse against devicemakers selling defective products under state tort laws. (FDAnews Device Daily Bulletin, Aug. 12, 2008, Vol. 5, No. 157, “Senators Introduce Their Version of Anti-Preemption Bill." See also 08/01/08 Statement of Senator Leahy.)

The bill seeks to reverse the United States Supreme Court’s February 20, 2008 decision in Reigel v. Medtronic in which the Supreme Court severely curbed the rights of injured victims. Specifically, this harsh decision held that the Federal Food, Drug and Cosmetic Act (FDCA) preempts state-law claims seeking damages for injuries caused by medical devices with premarket approval from the FDA.

Baxter and other drug manufacturers argue that Riegel should be even further expanded to include medical drugs. They argue that regardless of misconduct or failures on their part, Americans injured by defective drugs or medical devices should be stripped of their constitutional right to a trial by jury for most, if not all, legal claims, where the drugs or medical devices are regulated or approved by the FDA.

As discussed in previous blogs, this argument is not only legally and ethically problematic, but is based on the flawed assumption that the FDA has the resources, authority, and capability to ensure product safety. Unfortunately, as the heparin debacle as reminded us, such is not the case. Without accountability of companies who unapologetically put profits over people, innocent Americans will continue to die from unsafe drugs and medical devices.

To read Senator Leahy’s powerful statement regarding the bill and the dangers of preemption, click here.

We thank Senators Leahy and Kennedy for their efforts to protect the American public from unsafe drugs and medical devices.

Labels: Baxter, Baxter Heparin, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, Kennedy, Leahy

posted by Pamela A. Borgess # 4:41 PM 0 Comments

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