(BioWorld Today Via Acquire Media NewsEdge) Washington Roundup

WASHINGTON - Reps. Frank Pallone (D-N.J.) and Henry Waxman (D-Calif.) introduced their long-talked about bill that seeks to invalidate a February decision by the Supreme Court that immunized medical device makers against injury claims brought by patients in state courts.

The high court in Riegel v. Medtronic Inc. ruled that such lawsuits are barred by a preemption clause included in the Medical Device Amendments of 1976 (MDA).

The justices are set to hear a similar argument this fall involving drugs in the case of Wyeth v. Diana Levine, a Vermont woman who alleged she lost her arm from adverse events tied to Madison, N.J.-based Wyeth's nausea and motion sickness drug Phenergan (promethazine). (See BioWorld Today, June 9, 2008.)

The lawmakers have contended that the February device ruling is a flawed interpretation of the MDA, and that it has left consumers without the ability to seek compensation for medical expenses and lost wages resulting from injuries caused by defective devices or inadequate safety warnings imposed by the FDA.

In addition, the Democratic legislators argued that the court's decision essentially removes any incentive to maintain product safety after approval and disclose newly discovered risks. "The Riegel decision protects the financial interests of medical device companies at the expense of patients harmed by FDA-approved devices," Waxman charged. "If manufacturers face no liability, all the financial incentives will point them in the wrong direction: away from ensuring the safety of their medical devices. We must act quickly to address this dangerous situation," he said in a statement.

If enacted, the Medical Device Safety Act of 2008 "reverses an unfortunate Supreme Court decision that denied victims any legal recourse and gave medical device makers blanket immunity for the life of a product," Pallone stated.

The FDA has argued that regulatory approval of drugs and devices preempts the right of a consumer to sue a manufacturer in state court if a product later causes an injury.

Waxman, who convened a hearing in May of the House Oversight and Government Reform Committee, has charged that the Bush administration is attempting to subvert Congress and the Constitution by implementing federal rules that attempt to block consumers from bringing liability claims to the courts. (See BioWorld Today, May 15, 2008.)

The power to preempt state law and regulation, said Sen. Patrick Leahy (D-Vt.), "lies with Congress alone." The Vermont Democrat said he and Sen. Edward Kennedy (D-Mass.) plan to introduce soon a companion bill in the Senate.

"We must not forget that there are three co-equal branches of the federal government with distinct duties and responsibilities," said Rep. John Dingell (D-Mich.), who said the court's decision constricts state authority in a way Congress never intended.

"Therefore, Congress should exercise its authority to correct this judicial overreach," he said.

Congress Irked by Big FDA Bonuses

FDA bonuses in excess of $4,000 rose from $27 million in 2006 to $35 million in 2007, a 29 percent increase, Rep. John D. Dingell (D-Mich.), the chairman of the House Energy and Commerce Committee, revealed as part of an ongoing investigation into agency bonuses.

Federal workers in Washington earn an average of $88,000 a year. But bonuses doled out to some FDA top officials and other employees have pushed their annual pay to more than $200,000 - higher than what lawmakers and even cabinet secretaries earn.

The current annual salary for rank-and-file members of the 110th Congress is $169,300.

The speaker of the house, Rep. Nancy Pelosi (D-Calif.), earns the highest amount at $217,400, while the Senate and House majority and minority leaders' annual pay is set at $188,100.

Margaret O'Keeffe Glavin, who is stepping down this year as the agency's chief of regulatory affairs after a 40-year career at the agency, received nearly $50,000 in extra cash in 2007, while the highest bonus paid to an agency field inspector was $2,500.

"This is yet another example of the failure of FDA management to understand that its sole purpose for existence is to protect the American people from unsafe food, drugs and medical devices," Dingell declared. "These back-scratching bonuses could be used to hire inspectors that might have gone to China and uncovered the unsafe manufacturing practices that led to the heparin deaths, or the tomato packers that shipped salmonella to hundreds of Americans," he asserted.

Dingle acknowledged that some of the extra compensation paid to medical reviewers is justified. But, he charged, "millions of taxpayer dollars are being paid to people that perform no scientific function at all."

The Michigan Democrat said FDA bonuses should be used more to retain the agency's field work force, inspectors, lab analysts and other frontline employees "who have their fingers in an increasingly leaky dike."

Grassley Seeks Accountability from the NIH

The National Institutes of Health (NIH) has failed to conduct proper due diligence in monitoring conflicts of interest in taxpayer-sponsored medical research, Sen. Charles Grassley (R-Iowa) has charged.

The NIH, which awarded $24 billion in research grants this year, is required by law to monitor financial conflicts of interest by requiring the organizations that receive grants to collect and manage information on the funds the grantees receive from drug and device makers and other industries. However, that tracking has gone by the wayside, said Grassley, the ranking member on the Senate Finance Committee.

The Iowa Republican noted that the Department of Health and Human Services inspector general in January revealed that the NIH has done a poor job in monitoring its extramural grants for conflicts of interest. (See BioWorld Today, Jan. 22, 2008.)

"With the objectivity and integrity of research at stake, along with public trust in the system, there are plenty of reasons for Congress to step in to establish penalties for grantees who fail to report financial conflicts and to bring transparency to taxpayer-funded medical research," Grassley said.

He urged his colleagues in Congress who hold leadership positions on appropriations committees to hold the NIH accountable for monitoring conflicts of interest. n

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