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Articles from 2008 In February

Baxter Fined For Testing Inadequacies

They also failed to keep accurate and complete records of the safety inspections and maintenance tests, according to inspectors, who attributed the problems to "deliberate acts" committed by Baxter employees. The same facility was fined $44,000 in 2004 for violations that included not following safety protocols intended to protect employees from radiation exposure. Baxter has been under the spotlight recently for its blood thinner heparin that has resulted in several deaths. The company recalled nearly all of its heparin products this week. Baxter doesn't manufacture drugs at the facility where the irradiation device issues occurred.

Law on Doctor-Manufacturer Ties Must Be Strengthened, HHS Says

The statute requires the government to prove willful conduct, which makes it difficult to win cases, he explained. A bipartisan proposed bill would require device and drug firms to report all payments to doctors via an annual report that would be made public online. Not every payment is inherently sketchy, as device companies must rely on physician feedback during the device-development process. But it will help boost public confidence in the device industry if the payments are made part of the public record, and the public can distinguish the payments for legitimate purposes from the ones that are no more than pointless perks or sham consulting arrangements.

Senate Committee Hears Testimony on Payments to Doctors

Its chairman, Herb Kohl (D-WI), is proposing a bill that would mandate disclosure of consulting payments by device and drug companies with $100 million or more in annual revenues. AdvaMed has come out in favor of the bill, provided that it is amended to "protect legitimate payments to surgeons." Medtronic, too, issued a statement in favor, but is calling for the bill to apply to firms of all sizes.

Is Zimmer Oversight Really Political Patronage in Disguise?

The Washington Post reports that Ashcroft has agreed to testify before a House subcommittee on the monitoring arrangement, which could net his firm between $28 million and $52 million over 18 months. Congressional Democrats and some scholars are concerned whether such high fees are justified, and whether corporate monitorships are in danger of becoming tools for political patronage. Zimmer agreed to the monitoring in exchange for the government holding off on an indictment. It and four other orthopedics firms were accused of paying kickbacks to doctors as an incentive to use their products. Zimmer paid the largest fine of the five and is by far the largest company of the four that agreed to accept federal monitoring. It makes sense that Zimmer would have to pay the largest monitoring fee, but is $28 million or more really justified? The political intrigue is what gets the headlines, but the real issue is that there are no guidelines about how monitors are selected or about how they should be compensated. The Justice Department needs to establish some as soon as possible.

Knee Resurfacing Implant Launched

It is geared for patients who have damage in the medial or lateral compartments of the knee, but not in other parts. Each implant is designed from a patient's CT scan and is made specifically for that patient. The company says that because each implant is custom-designed, it allows for true resurfacing of the femur and complete coverage of each weight-bearing surface.

More Trouble for ProDisc Makers

(FDA and the New Jersey attorney general's office are investigating.) After his device failed, Calvin Timberlake sued Synthes, which currently owns the rights to ProDisc. Yesterday, he added Spine Solutions, the original developer of the product, and Viscogliosi Brothers, an investment firm that owned a major stake in Spine Solutions, to the suit. Synthes acquired Spine Solutions in 2003 for $350 million. The ProDisc received FDA approval in 2006. But here's the bombshell: The suit alleges that Viscogliosi Brothers had incentive to mislead FDA and get ProDisc approved so they could sell Spine Solutions and use the proceeds to "repay embezzled funds" and "prevent financial ruin and likely criminal indictment." Viscogliosi Brothers vigorously denied the allegations, saying all investigations against it were disbanded without charges. Synthes declined to comment. The Manhattan district attorney's office did investigate Viscogliosi Brothers in 2002, but declined to pursue charges, finding that investors were not swindled. Potentially more significant is the suit's claim that Viscogliosi Brothers set out to find surgeons for the clinical trial who would invest in its funds. That brings into play conflict-of-interest issues. The firms have said in the past that the surgeons' financial status had no bearing on the findings. Could this suit be tossed because of the "federal preemption" principle upheld in the Supreme Court this week? Not if the product is, or has the potential to be proved as, adulterated or misbranded. And Timberlake's lawyer says the conflict-of-interest issues raise questions about the validity of the data FDA used in its review. If the data turn out to be faulty, the product is misbranded. UPDATE: Sen. Charles Grassley (R-IA) has asked FDA and Synthes to provide information about what Synthes disclosed during ProDisc's application process, the New York Times reports.

Congressional Democrats Angry Over Medtronic Victory

Edward Kennedy, D-MA, told the New York Times that "Congress obviously needs to correct the Court's decision." He said that when Congress passed the Medical Device Amendments of 1976, it did not intend to give "blanket immunity to manufacturers from liability for injuries caused by faulty devices." Never mind that device companies do NOT have "blanket immunity" under the law. It still allows patients to sue in state courts when a PMA device fails to meet FDA standards -- i.e., is adulterated or misbranded. Over in the House, Rep. Henry Waxman, D-CA, was equally incensed. "The Supreme Court's decision strips consumers of the rights they've had for decades," he said, presumably in a prepared statement, as the quote showed up in both the Times and the Washington Post. "This isn't what Congress intended, and we'll pass legislation as quickly as possible to fix this nonsensical situation." As for legislation being passed as quickly as possible, the Democrats' best strategy may be to wait until next year. This sounds like an issue that will split along party lines, which means they won't have a veto-proof majority. And President Bush would likely veto such a bill, as his Justice Department sided with Medtronic. If the Democrats win the White House, though, the bill would stand much less of a chance of being vetoed next year. Unless, of course, the real motive is to engage in election-year populism and placate one of the party's biggest contributors, the trial lawyers. UPDATE: Waxman and Frank Pallone (D-NJ) said they will introduce a bill overturning federal preemption in April.

Medtronic Wins Supreme Court Case

The ruling, which pertained to a patient named Charles Riegel who was injured by a Medtronic catheter, was released this morning, reports the Associated Press. The lone dissenter, Justice Ruth Bader Ginsburg, said that Congress never envisioned "a radical curtailment of state common-law lawsuits" when it granted FDA ultimate authority to determine the safety and effectiveness of PMA products. 510(k) products are subject to suits in state courts because they have not been evaluated as rigorously. This is a victory not only for Medtronic, but for FDA and the device industry as a whole. A loss would have meant that state courts could have made their own determinations as to what constituted safety and effectiveness. This would have undermined FDA's authority, exposed device companies to increased liability, and potentially thrown the whole medical device regulatory system into chaos. Remember, patients can still sue if the product violated FDA regulations. This is not the stripping-of-legal-rights scenario that some will make it out to be.  

FDA Guidance Safeguards Off-Label Promotion

Transforming FDA LogoOn Friday FDA issued a draft guidance that would allow device companies to distribute articles from medical and scientific journals that discuss unapproved uses of medical devices. The "Good Reprint Practices" document has suggestions companies should follow when giving out journal reprints and other reference materials. Guidelines include that the article be peer-reviewed and published by an organization that has an editorial board, and that there's full disclosure of conflicts of interest. The guidance also recommends against distributing materials that have been funded by one or more of the manufacturers of the products in the article. FDA is currently seeking public comments on the draft guidance.

Give More Attention to Personalized Medicine

The concept provides an accurate and effective way of identifying a medical condition that is present or a person is trying to prevent, and provides the best way of dealing with it. Ludwig is hopeful that personalized medicine with not only pick up momentum here in the U.S., but on a global scale too. He anticipates that methods such as HPV screening, which is becoming more accurate with advances in technology to reduce cervical cancer incidences dramatically, will become a screening method used in other parts of world soon. Diagnostics that conduct rapid screening will also help treat patients who have contracted harmful infections in a matter of hours instead of days. While the idea of personalized medicine is quite promising for patients, let's hope that reimbursement will allow this innovative technology to actually be used on a widespread scale.