Significant Revisions to China’s Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 650) China’s State Council released its new Administrative Regulation on the Supervision and Administration of Medical Devices March 7, 2014, which will be effective June 1, 2014 (the New Regulation). The State Council Legislative Affairs Office worked more … Continue Reading
This post was written by Jillian W. Riley. Earlier this week, FDA’s Center for Devices and Radiological Health (CDRH) published two separate draft guidance documents to advance the dual goals of FDA and industry to provide pathways for medical devices to reach the market quickly while ensuring the safety and efficacy of the product. The … Continue Reading
This post was written by John Tan, Amy Yang, and Crystal Xu. In late December, China’s National Health and Family Planning Commission (NHFPC), the successor organization to the Ministry of Health, issued two sets of anti-corruption regulations for the health care industry: the 2013 Regulations on the Establishment of a Commercial Bribery Blacklist for the … Continue Reading
FDA recently released a draft guidance entitled "Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)," which discusses the risks of transmitting various forms of transmissible spongiform encephalopathies, including Mad Cow Disease (found in cattle), scrapie (found in sheep), chronic waste disease (found in deer), and Creutzfeldt-Jakob Disease (found in humans). The guidance is applicable to all medical devices that contain or are exposed to animal-derived materials, with the exception of in vitro diagnostic devices.… Continue Reading
Reed Smith’s Global Regulatory Enforcement Law Blog recently featured a post about the U.S. Treasury Department’s Office of Foreign Assets Control’s review of applications filed under the Trade Sanctions Reform and Export Enhancement Act of 2000. Although restrictions on the export and re-export of some medical devices and medicines were lifted a year ago, license … Continue Reading
The regulatory enforcement environment in China remains tense, as both the Chinese government and media bring new actions and allegations against life sciences manufacturers in both the pharmaceutical and device sectors. We are seeing: Increased attention to medical device sector Enforcement actions spreading to smaller cities Continued pressure on pharmaceutical sector Reports of misconduct by … Continue Reading
On August 15, 2013, the local Beijing office of the Ministry of Health (MOH) of the People's Republic of China announced (Chinese link) that it has started a three-month review of the use of high-value medical consumables and large-scale medical equipment in Beijing. In its announcement, the Beijing MOH noted that prior inspections of hospitals had found continuing problems with the misuse and overuse of medical devices to increase profits. The investigation is intended to strengthen hospitals' management of the use of medical devices and to regulate the use of high value medical consumables.… Continue Reading
Referencing what it deems a "proliferation" of physician-owned distributors (PODs), on March 26, 2013, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a Special Fraud Alert identifying significant concerns with such entities under federal anti-kickback principles.1 For purposes of the Alert, the OIG defines a POD as "any physician-owned entity that derives revenue from selling, or arranging for the sale of, implantable medical devices," including "physician-owned entities that purport to design or manufacture, typically under contractual arrangements, their own medical devices or instrumentation." Specifically, the OIG describes in somewhat unusual detail the multiple "attributes and practices" of PODs that the OIG believes "produce substantial fraud and abuse risk and pose dangers to patient safety."
Notably, the Alert is focused on PODs that derive revenue from selling, or arranging for the sale of, implantable medical devices that are ordered by physician-owners for use in procedures that physician-owners "perform on their own patients at hospitals or ambulatory surgical centers (ASCs)." However, the OIG states that "the same principles would apply when evaluating arrangements involving other types of physician-owned entities."… Continue Reading
Over at the Drug and Device Law Blog, there are several posts analyzing the meaning of the Second Circuit’s opinion in United States v. Caronia, 703 F.3d 149, 160 (2d Cir. 2012), including this one and this one. Most Caronia commentary has focused on the court’s First Amendment holding, that the FDCA does not ban … Continue Reading
This post was written by Jay J. Yan, Hugh T. Scogin, Jr., John J. Tan, Mao Rong, Katherine Yang, May Wong, Amy Yin and Gordon B. Schatz. Reed Smith’s China Life Sciences and Health Industry Client Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life … Continue Reading
On Wednesday, November 21, 2012, Massachusetts' Public Health Council ("Council") approved amendments to the State's Marketing Code of Conduct, which restricts certain gifts and payments by pharmaceutical and medical device manufacturers to Massachusetts health care practitioners ("HCPs") and requires disclosure of payments and transfers of value to HCPs. The final regulations, effective as of December 7, 2012, primarily adopt the emergency regulations issued by the State in September but make a few substantive changes.… Continue Reading
On September 19, 2012, the Massachusetts Public Health Council approved emergency amendments to the State's Marketing Code of Conduct regulations, 105 CMR 970.000, which restrict certain gifts and payments by pharmaceutical and medical device manufacturers to Massachusetts health care practitioners ("HCPs") and require disclosure of payments and transfers of value to HCPs. The regulations, effective as of September 19, 2012, follow amendments to the underlying statute, Massachusetts General Laws, Chapter 111N, signed into law in July by Governor Deval Patrick as part of the FY2013 State Budget.… Continue Reading
This post was written by Jay J. Yan, Hugh T. Scogin, Jr., John J. Tan, Mao Rong, Katherine Yang, May Wong, Amy Yin and Gordon B. Schatz. Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ Health … Continue Reading
Today the Office of the Vermont Attorney General announced that the Vermont Attorney General is offering limited amnesty to medical device and biologic manufacturers who have failed to report pursuant to Vermont's Prescribed Products Gift Ban and Disclosure Law. The offer will remain open until October 1, 2012. In order to take advantage of the offer, manufacturers must email prescribedproducts@atg.state.vt.us with the following information: (1) manufacturer name; (2) reporting periods not reported; and (3) name, address, email, and phone number of the representative with whom Vermont should communicate.… Continue Reading
This post was written by Jay J. Yan, Hugh T. Scogin, Jr., John J. Tan, Katherine Yang, May Wong and Gordon B. Schatz. Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries Some important … Continue Reading
As drug and device manufacturers continue to await final regulations and subsequent implementation of the federal Physician Payment Sunshine Act, passed as part of the Affordable Care Act, Massachusetts has relaxed its similar state law banning the provision by manufacturers of gifts to health care practitioners (“HCPs”) and requiring disclosure of payments and transfers of … Continue Reading
This post was also written by Ruth N. Holzman and Angelo Ciavarella. Yesterday the House approved by a vote of 270-146 legislation to repeal the ACA’s controversial 2.3% excise tax on the sale price of certain medical devices, which is scheduled to apply to sales after December 31, 2012. The repeal provision is included in H.R. 436, the … Continue Reading
This post was also written by Ruth N. Holzman and Angelo Ciavarella. A vote on legislation to repeal the ACA’s medical device excise tax could come in June, House Majority Leader Eric Cantor announced today. The ACA imposes a 2.3% excise tax on the sale price of medical devices sold by the manufacturer, producer, or importer of the … Continue Reading
Reed Smith's Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.… Continue Reading
The Centers for Medicare & Medicaid Services (CMS), tasked with implementing the Physician Payments Sunshine Act, announced yesterday that it will not require pharmaceutical, device, and other applicable manufacturers and group purchasing organizations (GPOs) to begin collecting reportable data before 2013. Once implemented, the Physician Payments Sunshine Act (Section 6002 of the Affordable Care Act) … Continue Reading
The New Hampshire State Senate held a hearing on April 19, 2012 regarding HB 1725, a new measure that would prohibit all health care practitioners from prescribing or referring any U.S. Food and Drug Administration class II or class III implantable medical device if the practitioner stands to "profit indirectly or directly from the sale of [the] medical device by any supplier in which the health care practitioner has a direct or indirect ownership interest."… Continue Reading
On March 29, 2012, the New Hampshire House of Representatives recommended for passage HB 1725. If passed, HB 1725 would prohibit all health care practitioners from prescribing or referring any U.S. Food and Drug Administration class II or class III implantable medical device if the practitioner stands to profit, directly or indirectly, from the sale of the device, or from performing any procedure involving the device.… Continue Reading
Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries. Some developments during March include: American Medical Device Maker Accused of Bribery to Doctors in China and other Countries Qiagen Inks HPV Screening Deal with … Continue Reading
This post was written by Jay J. Yan, Mao Rong, Zack Dong, Katherine Yang, Joyce Sun, Sara Lai and Gordon B. Schatz. Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries. Some important developments … Continue Reading
