Tag: manufacturers
Massachusetts Refines Its Sunshine Law; Final Federal Sunshine Regulations Moving Ahead
The relationship between health care providers and drug and device manufacturers has been a focus of lawmakers at both the federal and state level. While we continue to await final federal regulations implementing the Physician Payment Sunshine Act (federal Sunshine Act), which generally requires disclosure of financial arrangements among physicians, teaching hospitals, and drug and device manufacturers,[1] Massachusetts has refined its requirements governing relationships between physicians and drug and device manufacturers. Amendments to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct regulations[2] (the Massachusetts Regulations) broaden the scope of permissible meals and refreshments that may be provided by manufacturers to health care practitioners and clarify issues related to preemption of the Massachusetts Regulations by the federal Sunshine Act. The Massachusetts changes and impending release of final federal regulations underscore the continuing need for drug and device manufacturers to … Read More »
Are Biosimilars the Next Generation of Small Drug Manufacturers?
New reports suggest that while generic drug makers are aggressively consolidating in the United States and United Kingdom, smaller generic drug manufacturers’ viability is threatened, forcing them to seek niche therapeutic areas. Manufacturing biosimilar biologicals may be an answer for the smaller generic drug companies, due to several factors. First, while manufacturing complexities create market entry barriers, recent shortages of the biologics supply in the U.S. have increased the market demand. Also, low margins are causing large manufacturing companies to exit the biologics market. Furthermore, the patents for many top selling biologics will expire in the next 3 to 5 years, creating an opportunity for new market entrants. Finally, the new abbreviated approval pathway for biosimilars in the U.S. may be more conducive to the needs of smaller firms: efficient approval process, lower development costs, and protection for first generation biologics.
Background
In … Read More »
The FDA Proposes New Rule on Unique Medical Device Identification and Marking Requirements
The United States Food and Drug Administration (FDA) has proposed a rule establishing a unique device identification system for medical devices and requiring a unique device identifier (UDI) to be placed on medical devices and device packages. See 77 FR 40736 (July 10, 2012). The FDA intends the unique device identification system to reduce medical errors, create greater accuracy in adverse event reporting and post-marketing surveillance, and facilitate recalls. The proposed rule, which was promulgated in accordance with the Food and Drug Amendments Act of 2007, is the result of pilot testing and public input. The UDI requirements, process, and implementation schedule are of particular interest to medical device and instrument manufacturers, and will have an impact on manufacturing and supply chain operations. Comments on the proposed rule may be submitted to the FDA by November 7, 2012.
Goals of the … Read More »
Massachusetts Amends Its Drug and Device Marketing Law
On July 8, Governor Deval Patrick signed a bill amending the Massachusetts law regulating marketing activities by pharmaceutical and device manufacturers, one of the strictest state laws in the country.
The law previously barred pharmaceutical and device manufacturers from providing meals to health care practitioners outside the practitioner’s office or hospital setting. See 111N Mass. Gen. Laws § 2. The amendment will now permit pharmaceutical and device manufacturers to provide modest meals and refreshments outside of the practitioner’s office or hospital setting, if the meal or refreshment is furnished with a non-CME educational presentation for the purpose of providing bona fide medical information, and the meal is furnished in a venue and manner conducive to communicating information. The amendment directs the Massachusetts Department of Public Health to promulgate regulations to define “modest meals and refreshments.” Pharmaceutical and device companies, however, will … Read More »
U.S. Supreme Court’s Affordable Care Act Decision: Impacts on Life Sciences
The June 28, 2012 U.S. Supreme Court decision upholding the Patient Protection and Affordable Care Act (“Act”) impacts the life sciences industry in a number of ways, including impacts on innovation and compliance initiatives by medical device, pharmaceutical, and biotechnology companies.
Innovation
A number of provisions in the Act provide incentives and resources for product innovation. First, it is expected that more than 30 million Americans will obtain health care coverage on account of the Act. A bigger pool of Americans with health coverage to pay for treatment will yield growth in pharmaceutical sales and, perhaps, the ability to charge higher drug prices, which, in turn, could spur innovation. In addition, the Act created the Therapeutic Discovery Project Program, through which $1 billion in new therapeutic discovery project grants and tax credits will be awarded. In 2010, 2,923 companies specializing in biotechnology … Read More »
CMS’s Proposed “Sunshine” Regulations: Implications for Research
On Dec. 19, 2011, the Centers for Medicare & Medicaid Services (CMS) released a Proposed Rule to implement § 6002 of the Patient Protection and Affordable Care Act (PPACA), commonly referred to as the Physician Payment Sunshine Act (Sunshine Act). The Sunshine Act was included in PPACA to enhance disclosure and transparency of financial arrangements among physicians, teaching hospitals, and manufacturers of federally reimbursable drugs and biologicals and covered medical devices and medical supplies, and thereby reduce the risk of inappropriate financial incentives interfering with medical judgment and patient care. The Proposed Rule details requirements for processing and reporting payments by pharmaceutical, device, biological and medical supply “applicable manufacturers”1 to physicians and teaching hospitals that are “covered recipients.”2 The Proposed Rule also sets forth requirements for reporting ownership and investment interests held by physicians and their immediate family members in applicable … Read More »