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  • Regulatory NewsRegulatory News

    2016 CMS Data on Industry Payments to US Physicians, Hospitals: Company Breakdowns

    The US Centers for Medicare and Medicaid Services (CMS) on Friday released 2016 data on more than $8 billion in payments (which is on par with 2015 data) made by 1,481 pharmaceutical, biotech and medical device companies to more than 600,000 physicians and 1,146 hospitals. In total, CMS calculated that $2.8 billion was spent on general payments and $4.36 billion on research payments.  In its breakdown of the numbers, CMS says that more than $1 billion in 2016 was s...
  • Regulatory NewsRegulatory News

    FDA Commissioner Listed in CMS Database for Receiving Payments from GSK, AstraZeneca in 2015

    In what might turn out to be an odd mistake, the current US Food and Drug Administration (FDA) Commissioner Rob Califf was included in a database of pharmaceutical company payments to physicians updated by the US Centers for Medicare & Medicaid Services (CMS) on Thursday. The database says Califf received five payments from GlaxoSmithKline for travel, lodging, food and beverages, as well as a more than $5,000 consulting fee from AstraZeneca in 2015. In 2014, when he ...
  • India Requires Disclosure of Sponsor/Investigator Payments

    Applications for approval of clinical trials in India must now include information concerning the agreement as to the payments that will be made by the sponsor to the trial investigator, according to a notice issued by India's Central Drugs Standard Control Organization (CDSCO) on 30 August 2013. India's Good Clinical Practices (GCP) regulations require the sponsor to conclude a contract with the trial investigator or institution, which must define the relationship bet...
  • Feature ArticlesFeature Articles

    Should Regulatory and Reimbursement Be Linked?

    The functions of determining regulatory approval and reimbursement for a product traditionally have been at opposite ends of the development process. Historically, any product that received regulatory approval was reimbursed by payers. This is no longer the case in today's global market. While regulatory approval by a single body is still the basic requirement for commercializing a product, obtaining optimal reimbursement requires interaction with many diverse public an...
  • CMS Announces Planned Data Collection Under Sunshine Act Delayed Until 2013

    • 08 May 2012
    The US Centers for Medicare and Medicaid Services (CMS) announced 3 May it would postpone a planned data collection mandated by the Physician Payments Sunshine Act (PPSA) , saying it would not collect any information until 1 January 2013. CMS's 19 December 2011 proposed rule on Section 6002 or PPSA stipulated the agency would begin collecting data from manufacturers this year covering their payments, gifts and other forms of compensation given to physicians. The age...
  • Report: Regulations Banning Industry Gifts in India Still Taking Shape

    A set of long-awaited pharmaceutical marketing rules preventing companies operating in India from providing free products to doctors in order to drive sales has failed to take shape a year after the regulations were first proposed, reports The Economic Times of India . "More important policy matters such as drug pricing have taken precedence, pushing the marketing policy to the back seat," a source told The Times , adding it is still in early development stages. The m...
  • Big Pharma Faces Prospect of Big Fines in 2012

    • 23 January 2012
    Some of the world's largest pharmaceutical companies are facing "costly settlements" during 2012 thanks to aggressive investigations and enforcement by US agencies and a wide-ranging list of improper activities allegedly perpetrated by the pharmaceutical companies, according to an analysis by The Financial Times . US agencies are currently separately investigating Pfizer, GlaxoSmithKline, Merck, Baxter, Bristol Myers Squibb, Eli Lilly, AstraZeneca and Smith & Neph...