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  • Regulatory NewsRegulatory News

    Generic Industry Group Sues Maryland Over Price Gouging Law

    The Association for Accessible Medicines (AAM), a trade group representing US manufacturers of generic drugs and biosimilars, on Thursday sued Maryland over a new law that will impose fines on generic drugmakers if prices rise by too much or too quickly. Maryland Gov. Larry Hogan (R) allowed the generic drug price gouging bill,  HB 631 , to become law in June, though he did not sign the bill and expressed reservations about "unintended consequences" as well as "le...
  • Regulatory NewsRegulatory News

    Health Canada Opens Consultation on Mandatory Adverse Drug Reaction, Device Incident Reports

    Health Canada on Tuesday opened up a consultation on changes to the country's Food and Drug Regulations and Medical Devices Regulations that would make it mandatory for certain health care institutions to report serious adverse drug reactions (ADRs) and medical device incidents (MDIs). "Reports about serious ADRs and MDIs can be important signals of emerging safety issues. Such post-market observations can also lead to improved safety information about a product," ...
  • Regulatory NewsRegulatory News

    21st Century Cures: Shifting the Balance of Negotiating Power

    The new 21st Century Cures law has proven to be divisive, with both advocates and critics getting hyperbolic on the law’s potential impact on the drug and medical device industries, as well as on the US Food and Drug Administration (FDA). Critics have said, among other things, that the law will forever tarnish FDA’s ability to keep dangerous new drugs and devices from hitting the market, while advocates believe it will open the US to new cures, particularly for rare dise...
  • Regulatory NewsRegulatory News

    Obama Signs Chemical Safety Bill Into Law

    President Barack Obama on Wednesday signed into law a bill that will overhaul, for the first time in 40 years, the way chemical substances are regulated in the US. Although the new law, which updates the Toxic Substances Control Act of 1976, deals with regulations governed by the Environmental Protection Agency (EPA) rather than the US Food and Drug Administration (FDA), it integrates principles to replace and reduce animal-based tests with human-relevant methods to asse...
  • Regulatory NewsRegulatory News

    Vermont Governor Signs Bill With Possible $10K Fines for Drug Price Hikes

    Vermont Gov. Peter Shumlin (D) on Friday signed into law a bill that would highlight drugs that the state spends significant amounts of money on, and companies owning those drugs could be hit with up to $10,000 in penalties if the wholesale acquisition costs rise too quickly and they fail to disclose the reasons for such hikes. Shumlin said Friday the bill was directed at providing answers on why pharmaceutical companies, like Turing Pharmaceuticals, disproportionately h...
  • Regulatory NewsRegulatory News

    Natural Health Products Excluded From Vanessa's Law

    Following the recall of two herbal medicines for containing high levels of lead and arsenic , The Globe and Mail is questioning why a new drug safety law excludes natural health products from its provisions. Background The Protecting Canadians from Unsafe Drugs Act —commonly known as Vanessa's Law —came into effect on 6 November 2014, after years of campaigning for stricter drug monitoring mechanisms by Conservative Member of Parliament Terence Young. The law...
  • Regulatory NewsRegulatory News

    Critics Call for Canada to Bolster New Drug Safety Law, Clarify Reporting Requirements

    A critic of Canada's Protecting Canadians from Unsafe Drugs Act —commonly known as Vanessa's Law —argues that without improvements to the country's adverse drug reaction (ADR) reporting systems, the law will fail to meet its goal of improving drug safety. Background Vanessa's Law came into effect on 6 November 2014, after years of campaigning for stricter drug monitoring mechanisms by Conservative Member of Parliament Terence Young. The law was named for Young's d...
  • Feature ArticlesFeature Articles

    Canada and the Orphan Drug Framework--Where Are We Now?

    Canada, one of the few developed countries without an orphan drug policy, is finally in the last stages of developing one. In the past, when queried about the lack of a policy, representatives from the country’s food and drug regulatory agency, Health Canada, stated that physicians could apply to have patients receive a non-approved orphan drug through the Special Access Programme or through clinical studies (if conducted in Canada). For manufacturers of orphan drug...
  • Feature ArticlesFeature Articles

    Debarred, Denied, Restricted? Legal Responsibilities in Outsourcing

    • 29 April 2014
    • By
    Regulatory professionals frequently work with their supply chain colleagues to ensure all relevant documentation is provided for the export of goods from the country of origin. However, there are little-known US regulatory requirements with potentially significant administrative and criminal consequences for violation, and many manufacturers may not be aware of them. The US Departments of Commerce, State and the Treasury publish lists of US and international individuals a...
  • In Wake of Compassionate Use Debate, New Bill Promises Wider Access to Drugs and Devices

    New legislation introduced in the US House of Representatives this week would allow for the import, manufacture and sale of investigational drugs and devices meant to treat terminally ill patients. Overview and Background The bill, H.R. 4475, the Compassionate Freedom of Choice Act of 2014, comes in the midst of a long-running debate over whether current regulatory structures-and in particular FDA's Compassionate Use exemption process -is sufficient to treat termi...
  • Feature ArticlesFeature Articles

    Sunshine Act Reporting: Research Payments and Requests for Delayed Publication

    On 8 February 2013, the US Centers for Medicare and Medicaid Services (CMS) issued its final rule on the reporting requirements for certain payments and other transfers of value under the Patient Protection and Affordable Care Act ( PPACA ), commonly referred to as the Physician Payment Sunshine Act ( Sunshine Act ). 1 The types of payments, identifying information and classifications for such payments and transfers are outlined in the final rule and require manufac...
  • Obama Signs New FDA User Fee Bill for Veterinary Pharmaceuticals Into Law

    US President Barack Obama has signed into law a new piece of legislation that is set to increase the amount of funding given to the US Food and Drug Administration (FDA) by the veterinary pharmaceutical industry in the hopes of speeding up review and clearance times for product applications. Background The legislation, known as the  Animal Drug and Animal Generic Drug User Fee Reauthorization Act (ADAGDUFRA) , is an amalgamation of the Animal Drug User Fee A...