Entries categorized as ‘FDA’
Barry Meier reports in the New York Times on questions being put to cardiologists by Senators Grassley and Kohl regarding the propriety of financial ties between cardiologists and stent manufacturers. The article notes that the Cardiovascular Research Foundation (CRF) reported 2005 revenues of $47.2 million. Senators Grassley and Kohl are asking how much of those funds came from stent makers, including Abbott Laboratories, Medtronic, Boston Scientific, and Johnson & Johnson. In addition, the inquiry is focusing on 22 leading academic researchers.
Without taking anything away from the legitimate questions being raised about the need for transparency and disclosure in academic research, the questions skirt around a far more difficult issue: the relationship between physician compensation and physician decisionmaking.
Categories: Cardiology · FDA
Tagged: cardiologist, Cardiology, crf, grassley, kohl, physician compensation, stents
Reed Abelson questions the FDA medical device approval process in the New York Times. (“Quickly Vetted, Treatment Is Offered to Patients,” Oct. 26, 2008). In contrast to the extensive review process for medications are approved, the FDA has a streamlined process for approval of devices that limits review to whether the device does what its manufacturers claim:
Critics say the F.D.A.’s process for reviewing medical technology, under which medical devices have become a $75 billion-a-year industry in this country, is often too lax. More devices, they say, should get the same scrutiny applied to new drugs. While that process is not perfect, a new drug is typically studied in hundreds or even thousands of patients before the F.D.A. will approve it as safe and effective.
But under the fast-track review for most devices, a product’s effectiveness is never directly established. Regulators simply determine if the device does what its maker says it does — in MammoSite’s case, that it delivers radiation — and whether it poses any undue safety risks.
Once a device is approved by the FDA, physicians can use it freely and are not obligated to make any further disclosure regarding its proven efficacy or lack thereof. Critics have also suggested that Medicare actually rewards the use of new devices with higher compensation rates, despite their unproven status, thereby incentivizing physicians to adopt new devices.
Categories: FDA
Tagged: device, FDA
October 11, 2008 · 1 Comment
Drug maker Eli Lilly has agreed to pay $62 million to California and 31 other states in settlement of charges of improper off-label marketing of the antipsychotic drug Zyprexa. According to California Attorney General Jerry Brown, the settlement is the largest ever multi-state consumer protection-based settlement with a drug company.
Zyprexa is approved by the FDA for treatment of schizophrenia or acute bipolar disorder. Beginning in 2001, Eli Lilly had marketed Zyprexa aggressively for various off-label uses, including treatment of symptoms of dementia and less acute conditions. Among other things, the drug carries a high risk of diabetes and weight gain as side effects, which the lawsuit alleged were not adequately disclosed to healthcare providers.
The Zyprexa settlement is only one of several stories of off-label marketing that have garnered attention recently. For example, although four years have passed since Pfizer paid over $400 million (and one of its subsidiaries pled guilty to criminal charges) to settle off-label marketing charges of the epilepsy medication Neurontin, the Wall Street Journal reported earlier this week on new information about suppression of unfavorable studies that have surfaced in ongoing litigation against Pfizer.
Recommended Action: Although drug companies are prohibited from advertising their drugs for uses not specified on the label, the practice of off-label marketing remains far from uncommon. While doctors should be wary of such promotion, physicians are permitted to prescribe FDA-approved medications for off-label uses they deem appropriate, as long as they do so on the basis of scientific evidence. A growing trend — and recommended practice –is to obtain informed consents for medications generally and to disclose if and when a drug usage is off-label and/or experimental. Providers can also protect themselves by providing scientifically balanced information about off-label uses.
Harry Nelson is a partner in Fenton & Nelson, LLP. Fenton & Nelson counsels physicians and other healthcare providers on regulatory compliance and business matters, including informed consent and practice management. For additional information, please contact him at harry@fentonnelson.com
©Harry Nelson 2008
Categories: FDA
Tagged: lilly, off label, zyprexa
Medical device maker Medtronic has been accused of paying physicans kickbacks — again. In 2006, Medtronic paid the U.S. Department of Justice $40 million to settle allegations that it had paid physicians to use its spinal repair products. Last month, the Wall Street Journal reported that Medtronic allegedly entertained surgeons at a strip club, sent them on fully paid trips to Alaska, and awarded some royalties on inventions they had no part in developing — all as inducements to support off-label use of Medtronic spine products. (David Armstrong, “Lawsuit Says Medtronic Gave Doctors Array of Perks,” Sept. 25, 2008.) Weeks earlier, the Journal also reported serious complications in patients who received the same off-label use of Medtronic’s “Infuse Bone Graft” device.
Recommended Action: Medtronic’s recurring problems should serve as a reminder for healthcare providers about the value of exercising caution in accepting benefits from drug and device makers. Providers need to balance the value of supporting promising, innovative drugs and devices that benefit patients, on one side, against the risks of accepting enticements that create appearances of impropriety on the other. Providers who accepted payments and benefits from Medtronic have paid a heavy price not only by having been linked to this story but also by having been named as defendants in and forced to defend several “whistleblower” lawsuits filed against Medtronic. Moreover, providers risk liability if problems ensue from the off-label use of Infuse. Ultimately, providers need to protect themselves by investigating further.
Harry Nelson is a partner in Fenton & Nelson, LLP. Fenton & Nelson counsels healthcare providers on regulatory compliance and business matters. For additional information, please contact him at harry@fentonnelson.com
©Harry Nelson 2008
Categories: FDA · Healthcare Marketing
Tagged: kickback, medtronic
In July 2008, the U.S. pharmaceutical industry announced a revised code of conduct for its dealings with health providers. The industry action was spurred by the “Physician Payments Sunshine Act” sponsored by Senator Charles Grassley, a proposed federal law that would compel researchers to disclose fully any financial connections to drug companies.
In recent weeks, the call for transparent relationships between drug companies and doctors has gained prominence in two recent stories. First, Eli Lilly and, shortly thereafter, Merck announced their intention to begin posting online databases of all payments to physicians for speaking and consulting beginning in 2009.
Second, on October 3, the New York Times published the latest in a string of recent stories of physician nondisclosure of payments from so-called “big pharma,” in this case that Emory University psychiatrist Charles Nemeroff, M.D. failed report over a million dollars of income from drug makers, in violation of federal research rules. This follows similar stories about prominent researchers at Harvard, University of Cincinnati, and Stanford is adding “fuel to the fire” and increasing the likelihood of significant federal limitations on the relationships between physicians and drug companies.
Recommended Action: The attention that drug (and device) company payments to doctors are receiving may be out of line with the scope of the problem, but the momentum on this issue is unmistakable. Both the pharmaceutical industry and the American Medical Association are responding to public perception in supporting Senator Grassley’s efforts, and each new story in the lead-up to the passage of the bill strengthens this perception and creates the risk of even stricter rules.
The reality is that a very narrow group of academic physicians (who, in turn, are a narrow constituency within physicians) receive compensation from pharmaceuticals for speaking about drugs or advising on drug development or drug trials. As for the broader distribution of small benefits, such as “the routine provision of office breakfasts and lunches, or the occasional invitation to educational dinners at fancy restaurants,” it is difficult to believe that these benefits have significant, long-term impact on physician decisionmaking. The real issues in the relationship between physician compensation and decisionmaking, however, may be too compex to be addressed. In the meantime, it is unquestionably a good practice to ensure transparency and appropriate disclosure of financial interests in all healthcare businesses.
Harry Nelson is a partner in Fenton & Nelson, LLP. Fenton & Nelson advises physicians and other healthcare providers in regulatory compliance and business matters. For additional information, please contact him at harry@fentonnelson.com
©Harry Nelson 2008
Categories: FDA
Tagged: disclosure, eli lilly, pharmaceuticals, physician compensation
As reported by Adam Liptak in the New York Times, the first case to be heard by the U.S. Supreme Court in its October 2008 term (October 6, 2008) addresses the legal effect of Food and Drug Administration (FDA) approval of drug labeling. Wyeth v. Levine involves a physician assistant (P.A.) error in 2000. Diana Levine, a professional musician, sought treatment for severe migraines. When the P.A. administered the treatment Levine had received in the past – Demerol for pain and Phenergan for nausea – the P.A. injected the Phenergan via “IV push,” thinking she was injecting into a vein, but missing and injecting intra-arterially. Although Phenergan is typically safe if administered intramuscular or through intravenous drip, it causes “swift and irreversible” gangrene when “exposed to arterial blood.” Ms. Levine lost her right hand and arm below the elbow to gangrene.
She sued both the clinic and Phenergan’s manufacturer, Wyeth on the basis that its label, approved by the FDA, did not disclose the risk of danger of administration by IV push. The label did warn that “inadvertent intra-arterial injection” could cause “gangrene requiring amputation,” but made no mention of IV push. Wyeth contended that the FDA rejected a proposed change, but Levine argued that Wyeth could still have supplemented the labelling. Although the clinic settled, Wyeth declined to do so, arguing that it claims of deficient drug labeling were preempted by FDA approval. The difference is that FDA regulations require only minimum safety standards, in contrast to state law, which imposed stricter warning requirements. A jury found in favor of Ms. Levine, and the Vermont Supreme Court upheld the decision , finding that FDA minimum safety labeling requirements “provide[d] a floor, not a ceiling, for state regulation.”
Recommended Action: Plaintiffs’ lawyers are concerned that pharmaceuticals may be insulated from inadequate drug labelling if the U.S. Supreme Court agrees with Wyeth and the FDA’s position that states are preempted from imposing additional safety requirements on medications. As reflected by the fact that the clinic settles with Ms. Levine even as the drug maker fights on, healthcare providers don’t have the same luxury as manufacturer of reliance on FDA labelling. A growing trend and “best practice” among physicians is the use of informed consents to advise patients fully of all risks associated with particular medications. We recommend that providers review the medications used in their practice and consider implementation of informed consents to avoid claims of inadequate disclosure of risks.
Harry Nelson is a partner in Fenton & Nelson, LLP, a law firm that counsels healthcare providers on FDA-related and other compliance issues. For additional information, please contact Fenton & Nelson at harry@fentonnelson.com
©Harry Nelson 2008
Categories: FDA
Tagged: drug, informed consent, medication
In the aftermath of “high-profile drug scares” such as Vioxx in recent years, the Food and Drug Admininistration (FDA) has become increasingly conservative in its approval of new drugs. (“Sick Patients Need Cutting-Edge Drugs,” Wall Street Journal 8/23/2008) . Gregory Conko, senior fellow at the Competitive Enterprise Institute, describes the difficulty faced by patients unable to gain admission to clinical testing programs for experimental drugs in obtaining “compassionate-use” exemptions to receive unapproved medicines.
With a drop in FDA drug approvals (53 in 1996 and 39 in 1997, only 16 in 2007 and 18 expected in 2008), access to new drugs seems to be getting worse as a result of increased fear that serious drug risks may not become apparent until additional rounds of testing. A proposed federal statute, the Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (“ACCESS”), H.R. 6270, would make beneficial new drugs earlier once they pass Phase I of FDA approval and have preliminary evidence of their effectiveness, may significantly increase physician access to experimental drugs.
Recommended Action: In light of more active FDA enforcement, providers need to take care that they are not placing themselves at risk of FDA action through the use of unapproved drugs. Prescription or dispensation of unapproved drugs, barring a change in federal law, exposes providers to criminal liability. Even if ACCESS or other changes in the law ultimately afford greater access to new drugs through a preliminary approval process, providers should always take care to ensure that full informed consent is obtained and documented carefully for all drug usage, and that informed consents call attention to the status of the drug and any off-label usage.
Harry Nelson is a partner in Fenton & Nelson, LLP. Fenton & Nelson counsels healthcare providers on FDA and other compliance issues. For additional information, please contact Fenton & Nelson at harry@fentonnelson.com
©Harry Nelson 2008
Categories: FDA
The New York Times reports on a Supreme Court ruling that federal law bars lawsuits “challenging the safety or effectiveness of a medical device,” as long as the device is marketed in a form that received premarket approval from the Food and Drug Administration (FDA). The case, In re Estate of Riegel v. Medtronic involved the bursting of a balloon catheter that injured a patient undergoing angioplasty. The patient and his wife sued Medtronic, maker of the catheter, on the theory that the patient had been injured by design, label, and manufacturing defects that violated New York state law. The Court ruled, however, that the FDA’s premarket approval prevented Medtronic from being sued over flaws.
The ruling applies only to medical devices that receive “premarket” approval, as opposed to the more common and streamlined process requiring a device maker only to prove substantial similarity to a device already on the market. Justice Scalia’s decision observed that the “premarket” approval process requires extensive review (1,200 hours on average) and grants approval only upon finding a “reasonable assurance” of the device’s “safety and effectiveness.”
The decision is expected to have a limiting effect on other cases involving FDA-approved medical devices.
Recommended Action: Providers can take little comfort from the protection extended to device makers as a result of the Riegel decision. FDA approval may protect providers from direct FDA action, but will not prevent patient suits if risks associated with a device are not fully disclosed. Fenton & Nelson encourages providers to review medical device usage to ensure appropriate risk disclosuresare being made .
Harry Nelson is a partner in Fenton & Nelson, LLP, a law firm that counsels healthcare providers on FDA-related and other compliance issues. For additional information, please contact Fenton & Nelson at harry@fentonnelson.com
©Harry Nelson 2008
Categories: FDA
