Reed Smith’s Global Regulatory Enforcement Law Blog features a post on a recent decision by the French Supreme Administrative Court (Conseil d’Etat) that expands the scope of the French Sunshine Act. “French Supreme Administrative Court Decision Significantly Broadens the Scope of the French Sunshine Act,” written by Reed Smith attorneys Daniel Kadar and Caroline Gouraud, … Continue Reading
The social media phenomenon has radically transformed the ways in which commercial businesses promote their services and products. However, as a result, companies must consider potential legal risks from an entirely new angle. To become a successful user of social media, a company must draft, review, disseminate and enforce a social media policy that addresses potential legal issues while at the same time emphasizing positive exposure for the business.… Continue Reading
The UK Medicines and Healthcare Products Regulatory Agency has directed Marketing Authorisation Holders (MAHs) for medicines containing specified controlled drugs to update their Summary of Product Characteristics, patient information leaflets, and product labeling. These new warnings are designed to make it easier for the government to enforce a new law prohibiting driving under the influence … Continue Reading
This post was written by John Wilkinson, Nicola Maguire and Adam Lewington. In November 2013, the Human Medicines (Amendment) (No.2) Regulations 2013 (the “Amendment”) came into effect, amending the Human Medicines Regulations 2012, which set out a “comprehensive regime for the authorisation of medicinal products for human use; for the manufacture, import, distribution, sale and … 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
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
On May 26, 2011, Vermont Governor Peter Shumlin signed into law Senate Bill 104 ("S.104"), significantly modifying Vermont law banning the provision by manufacturers of gifts to health care providers and requiring disclosure of certain allowable expenditures and gifts to health care providers (18 V.S.A. § 4631a and 18 V.S.A. § 4632). S.104 follows amendments made to the Vermont gift ban and disclosure law enacted just last year. This Client Alert includes a summary of the modifications pursuant to S.104. Except as otherwise noted, the changes are effective July 1, 2011.… Continue Reading
States are increasingly imposing marketing restrictions on device manufacturers through laws that previously focused more specifically on pharmaceutical manufacturers. These laws affect compliance activities and relationships with providers, and create new reporting obligations. The impact is significant in that these state laws directly influence how companies conduct business and interact with customers, but implementation is complicated by the variations that exist between states.
Most significantly, under the federal Patient Protection and Affordable Care Act ("ACA"), beginning March 31, 2013, and annually thereafter, device manufacturers must report payments to physicians and teaching hospitals during the preceding calendar year. This means manufacturers must be prepared to track payments in a comprehensive manner as of January 1, 2012. The Centers for Medicare & Medicaid Services ("CMS") is now in the early stages of developing specific provisions to implement the new ACA provisions, with publication of proposed regulations to occur not later than October 1, 2011.
This Client Alert provides a brief overview of the existing state marketing laws that apply to device manufacturers, including recent changes to those laws, as well as federal reporting requirements under the ACA. Although the laws discussed may apply broadly to other entities, we refer in our Client Alert specifically to medical device manufacturers.… Continue Reading
The Federal Communications Commission ("FCC") has proposed changes to its Telephone Consumer Protection Act ("TCPA") rules that would conform to the Federal Trade Commission's Telemarketing Sales Rule ("TSR"). The primary change in the regulations would affect the sending of prerecorded messages (a/k/a "robocalls") by barring them even to existing customers without first obtaining prior written consent. At first blush, this seems routine, but because of differences in the FCC's and FTC's statutory jurisdiction, there are complicated implementation issues that could trap unsuspecting companies. Other key issues for the health care industry is whether the FCC should create an exemption for prerecorded messages that are subject to Health Insurance Portability and Accountability Act ("HIPAA") and, if so, how such exemption should be implemented. For more information about these changes, please read our client alert written by Robert Jackson.… Continue Reading