RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    Biotech Company Settles With SEC Over Failure to Disclose FDA Concerns

    The Securities and Exchange Commission (SEC) on Tuesday settled fraud charges against Massachusetts-based biotech company AVEO Pharmaceuticals for $4 million after three former executives allegedly concealed the US Food and Drug Administration’s (FDA) level of concern about approving the cancer drug tivozanib in public statements. SEC had alleged that AVEO concealed FDA’s concerns with tivozanib in statements to investors by omitting the critical fact that FDA staff had ...
  • Regulatory NewsRegulatory News

    B-MS Pays $14M to Settle SEC Charges over Bribing Health Providers in China

    Bristol-Myers Squibb (B-MS) on Monday agreed to pay more than $14 million to the Securities and Exchange Commission (SEC) to settle charges that its joint venture in China made cash payments and provided other benefits to health care providers (HCPs) at state-owned and state-controlled hospitals in exchange for prescription sales. The payment comes as SEC found B-MS violated the Foreign Corrupt Practices Act (FCPA) and reaped more than $11 million in profits from its mis...
  • Mischaracterization of Regulatory Problems Leads SEC to Charge Medical Device CEO with Fraud

    The US Securities and Exchange Commission (SEC) has announced it has charged a medical device executive for purportedly lying to investors about how regulators with the US Food and Drug Administration (FDA) had characterized an imaging device made by the company, which at the time had just been denied clearance under the 510(k) pathway by FDA. Background Under US law, to the extent that corporate officials communicate with their public investors, they must be truthful. ...
  • SEC Out with New Social Media Policy, But Parallels for FDA are Few

    For the second time in as many weeks, a major regulatory agency has announced the release of a new social media policy governing interactions between companies and the customers they serve, again permitting the practice within certain reasonable limits. The difference: This agency is the Securities and Exchange Commission, which, along with the US Food and Drug Administration (FDA), oversees one of the most stringent and complex regulatory areas in the entire US economy. ...
  • FDA Debars Former CDER Employee for Participation in Insider Trading Scheme

    Former US Food and Drug Administration (FDA) chemist Cheng Yi Liang almost certainly won't be finding work in the life sciences sector once he gets out of prison for profiting from the information he learned as an employee within FDA's Center for Drug Evaluation and Research (CDER). Background Liang worked as a chemist at FDA, where investigators said he had broad access to its Documents Archiving, Reporting and Regulatory Tracking Systems (DAARTS), which the agency use...
  • DOJ Officials Release 'Unprecedented' Guide on Anti-Corruption Law

    It can be difficult for companies-especially ones whose products are sold around the world, as many healthcare products are-to ensure every one of their employees are acting ethically and in accordance to the law. US Department of Justice (DOJ) officials would like to make it a bit easier for those companies to comply with at least one anti-bribery law: the Foreign Corrupt Practices Act . The legislation, originally passed in the 1970s after congressional investigators ...
  • Pfizer Settles With SEC Over Charges it Bribed Foreign Regulatory Officials

    Pharmaceutical manufacturing giant Pfizer has settled corruption charges leveled against it by the Securities and Exchange Commission (SEC) and the Department of Justice (DOJ), both of which said the company had violated the Foreign Corrupt Practices Act (FCPA) by bribing foreign officials to win business and allow its products to access markets. SEC said in a statement the company and its agents had bribed officials in Bulgaria, China, Croatia, the Czech Republic, I...