Physicians participating in North American Spine Society (NASS) activities will have to disclose the actual dollar amounts of all relationships with medical device companies in the 12 months preceding disclosure.
The policy applies to members and nonmembers of NASS and is stricter than the society’s previous policy, according to a NASS press release.
The policy is not a voluntary guidance, but “a binding covenant,” according to the press release. Members who fail to abide by the rule could face suspension of membership, expulsion, and public letters of censure. They could also be barred from presenting at future NASS meetings.
NASS’ announcement is part of a larger trend toward transparency regarding industry relationships with physicians. In January, Senators Charles Grassley (R-IA) and Herb Kohl (D-WI) introduced the Physician Payments Sunshine Act of 2009, which would require pharmaceutical, biologics, and medical device companies to report payments totaling more than $100 annually that they give to physicians.
Manufacturers are also stepping up transparency efforts. Edwards Lifesciences announced in December 2008 that it would begin posting information about physicians whom it pays $5,000 or more per year in consulting fees, royalties, or honoraria. In addition, AdvaMed released an updated Code of Ethics on Interactions with Health Care Professionals, which goes into effect on July 1. The new Code is designed to help eliminate even the appearance of impropriety in medical device manufacturers’ interactions with healthcare professionals.
InnoMed failed to abide by current Good Manufacturing Practices (GMPs) at its Coconut Creek, FL, facility, according to an FDA warning letter.
InnoMed did not conform to GMP requirements of the Quality System regulation because it did not establish and maintain procedures adequate for implementing corrective and preventive actions, did not test the design under actual or simulated use conditions, and did not create procedures for quality audits. InnoMed also failed to develop, maintain, and implement required written medical device reporting procedures.
RespCare and InnoMed Technologies, which operate at the same address and under the same management, manufacture continuous positive airway pressure interface devices for respiratory problems and sleep apnea.
Employees who walk in to the compliance officer’s office to report a suspected compliance violation are often the most credible sources, according to Jim Shehan, vice president and general counsel for Novo Nordisk in Princeton, NJ.
Speaking at the Center for Business Intelligence’s Pharmaceutical Compliance Congress in Washington, DC, January 26, Shehan said most people who come into the compliance office have a lot invested in the potential problem. They have seen something that raises questions and have decided they need to do something about it.
The number of walk-ins also directly corresponds to how comfortable people are with the person to whom they report violations, added Jeanine Jiganti, vice president and chief compliance officer with Takeda Pharmaceuticals in Deerfield, IL. She recommended compliance officers get out into the company so people get to know and trust them.
Shehan also encouraged compliance officers to publicize the anonymity of the compliance hotline. Even though companies can do everything possible to make hotlines anonymous, Shehan said companies will “never get away from direct reports. People view anonymous reporting as sneaky and they won’t do it.”
Compliance, Jiganit said, comes down to corporate culture and building trust. Compliance professionals need to be “as accessible as we can be.”
Medical device manufacturers may soon be required to submit all class III devices to the more stringent pre-market approval (PMA) process instead of the 510(k) pre-market notification process.
New devices must clear FDA pre-market review through either the 510(k) pre-market notification process, which determines whether a new device is substantially equivalent to another legally marketed device, or the PMA process, which requires the manufacturer to supply evidence that the device is safe and effective. The Safe Medical Devices Act of 1990 required that FDA either reclassify or establish a schedule for requiring PMAs for class III devices.
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Another health system will publicly disclose payments made to its physicians by the pharmaceutical and medical device industries.
Park Nicollet Health Services, located in Minnesota, will begin requiring physicians to disclose their financial ties to pharmaceutical and medical device companies, according to a press release.
Physicians have a duty to patients to “disclose, avoid, and minimize the influence of any conflicts of interest that may arise from consulting and speaking relationships” with pharmaceutical and medical device companies, the release states. Park Nicollet will post the disclosures online.
In December 2008, the Cleveland Clinic announced it would post information online for all 1,800 of its physicians and scientists, detailing their education, professional experience, specialties, and ties to industry. The same week, Penn Medicine announced its plan to launch a Web site by the spring of 2009 containing searchable information on all outside activities of its doctors and scientists.
Senators Charles Grassley (R-IA) and Herb Kohl (D-WI) continue to push for national legislation requiring pharmaceutical and medical device companies to disclose payments to physicians.
The senators introduced the Physician Payments Sunshine Act of 2009, which would require pharmaceutical, biologics, and medical device companies to report payments they give to physicians over $100 every year, according to a Grassley press release. The new bill is similar to the Physician Payments Sunshine Act of 2007, which Congress failed to vote on, but reduces the threshold for reporting from $500 to $100.
Payments would be posted online and available to the public. Companies could face fines of up to $1 million for knowingly failing to report payments.
Some pharmaceutical companies already announced plans to disclose payments to physicians, while health systems such as the Cleveland Clinic and Penn Medicine also plan to publicly disclose physician payments from industry.
Grassley is considering whether the reporting should also apply to payments made by industry to medical organizations, hospitals, pharmacy benefit managers, pharmacists and pharmacies, continuing medical education groups, and medical schools.
Senators Charles Grassley (R-IA) and Herb Kohl (D-WI) continue to push for national legislation requiring pharmaceutical and medical device companies to disclose payments to physicians.
The senators introduced the Physician Payments Sunshine Act of 2009, which would require pharmaceutical, biologics, and medical device companies to report payments totaling more than $100 annually that they give to physicians, according to a Grassley press release. The new bill is similar to the Physician Payments Sunshine Act of 2007, which Congress failed to vote on, but reduces the threshold for reporting from $500 to $100.
Payments would be posted online and available to the public. Companies could face fines of up to $1 million for knowingly failing to report payments.
In early January, Edwards Lifesciences announced plans to disclose payments to physicians. Health systems such as the Cleveland Clinic and Penn Medicine also plan to disclose publicly physician payments from industry.
Grassley is considering whether the reporting should also apply to payments made by industry to medical organizations, hospitals, pharmacy benefit managers, pharmacists and pharmacies, continuing medical education groups, and medical schools.
More information about physician ties to the pharmaceutical and medical device industries will soon become public.
Park Nicollet Health Services, located in Minnesota, will begin requiring physicians to disclose their financial ties to pharmaceutical and medical device companies, according to a press release.
The health system said physicians have a duty to patients to “disclose, avoid, and minimize the influence of any conflicts of interest that may arise from consulting and speaking relationships” with pharmaceutical and medical device companies. Park Nicollet will post the disclosures online.
In 1993, Minnesota passed a law that requires pharmaceutical companies to disclose their relationships with Minnesota physicians. Legislators are considering whether to require disclosures from medical device companies as well.
Medical device manufacturers may soon be required to submit all class III devices to the more stringent pre-market approval (PMA) process instead of the 510(k) pre-market notification process.
New devices must clear FDA pre-market review through either the 510(k) pre-market notification process, which determines whether a new device is substantially equivalent to another legally marketed device, or the PMA process, which requires the manufacturer to supply evidence that the device is safe and effective. The Safe Medical Devices Act of 1990 required that FDA either reclassify or establish a schedule for requiring PMAs for class III devices.
The FDA cleared submissions for 24 types of class III devices through the 510(k) process in fiscal years 2003–2007, according to a Government Accountability Office (GAO) report. These submissions were more likely than class I or class II submissions to be implantable or life sustaining, or to pose a significant risk to a patient. As of October 2008, four of the 24 device types had been reclassified, but 20 class III device types could still be cleared through the 510(k) process.
The GAO recommended the FDA issue regulations to:
- Reclassify each device type into class I or class II, or require it to remain in class III
- For those device types remaining in class III, require approval for marketing through the PMA process
E-mails between GlaxoSmithKline (GSK) researchers allegedly show they were concerned about the possible increase in cardiac risks associated with the company’s diabetes drug Avandia at the same time GSK publicly refuted similar conclusions in a New England Journal of Medicine article, according to a Wall Street Journal article.
In 2007, Cleveland Clinic cardiologist Steven Nissen conducted a meta-analysis that showed patients taking Avandia had a 43% higher risk for a cardiac incident. The internal e-mails allegedly show GSK scientists reached similar conclusions. The company said it did not hide the fact that its analysis reached similar conclusions and provided that information to the FDA.
In response to Nissen’s article, GSK released preliminary results of its own study called Record. According to the GSK study, Avandia might increase cardiac risks, but did not increase the likelihood of a heart attack or death.
The article prompted congressional investigations into GSK’s marketing of Avandia and the FDA’s response to the safety concerns. Senator Charles Grassley (R-IA) wants the FDA to request that GSK withdraw Avandia from the market and is preparing a report containing excerpts from the company e-mails, according to the Wall Street Journal. That report could be used to bolster lawsuits filed by approximately 1,000 people who claim to have suffered heart related problems after taking Avandia.