• Brazil: Risk Management Plans Shouldn't Prevent Drug Access for Generic Companies

    A proposed new standard that defines the criteria for inclusion and exclusion of drugs in list of drugs used as the reference drugs by generics (Reference Listed Drug) was adopted by the Board of Brazil's national regulatory agency, Anvisa, on 14 June. A key provision of the proposal would require the reference drug manufacturer to provide the drug for purchase by a generic company. The purpose of the provision is to ensure that generic companies can obtain the d...
  • Post-FDAAA, Regulators Move to Adapt to Changing Risk Models

    With all the attention given to the US Food and Drug Administration's (FDA) approval process, it can sometimes be easy to forget an equal amount of its time is spent on postmarketing issues related, in part, to product safety. Two components of assuring a product's safety involve adverse event reporting (AER) and risk management plans, both of which were the focus of a presentation given at Harvard Medical School in early May 2012. In his presentation, Dr. Gerald Dal Pan...
  • Report: REMS Preventing Companies From Making Generic Medicines

    The Food and Drug Administration (FDA) Amendments Act of 2007 allowed FDA to institute risk management plans-known as Risk Evaluation and Mitigation Strategies (REMS)-for products with a high probability of misuse or dangerous side effects. Now, manufacturers of generic medicines are claiming a side effect of the REMS policy is just as dangerous: restrictive REMS policies are preventing them from obtaining samples of medicines they need to make generic copies. The ...
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    Considering Risk Evaluation and Mitigation Strategies (REMS)

    Every drug comes with some risk. The key issue for regulators, drugmakers, healthcare professionals and patients alike is whether the likely benefit is greater than the risk. This is the question reviewers at the US Food and Drug Administration (FDA) must grapple with in determining whether or not to approve a new product or to leave an already approved product on the market in light of new information about adverse events or other potential negative consequences. In some...
  • FDA Looking to Develop Further REMS Guidance, Release Issue Paper

    The US Food and Drug Administration (FDA) is planning a workshop to gather feedback and information it can use to develop guidance for industry on the best practices for assessing goals associated with Risk Evaluation and Mitigation Strategy plans. The workshop, announced in a 2 May Federal Register posting, will take place on 7 June 2012. "The purpose of the public workshop is to initiate constructive dialogue and information-sharing among regulators, researchers, th...
  • IOM Issues Report on Studying Safety of Approved Drugs

    The Institute of Medicines (IOM) has released a consensus report on ways to improve the US Food and Drug Administraiton's (FDA) oversight of the safety of already-approved drug products. The report, entitled Ethical and Scientific Issues in Studying the Safety of Approved Drugs , explores a paradox often faced by FDA: only products that are safe should be approved, but the true safety profile of a product is difficult to ascertain until it has been used in real-world co...
  • Report: FDA Meeting Review Goals Under PDUFA

    The Government Accountability Office (GAO), the government agency tasked with reviewing and auditing government programs, has found the US Food and Drug Administration (FDA) to be meeting its performance goals for reviewing applications under the terms of the Prescription Drug User Fee Act (PDUFA) . GAO's report to Congress notes FDA has generally "met performance goals for priority and standard New Drug Applications (NDAs) and Biologic License Applications (BLAs) recei...
  • Industry Comments Indicate Displeasure with Medication Guides, FDA Looking at Single-Page Versions

    • 26 April 2012
    Comments on the US Food and Drug Administration's (FDA) Medication Guide requirements for prescription drug labeling indicate displeasure with the requirements, which are referred to as onerous, costly, excessive, poorly executed and otherwise burdensome. The comments, contained in FDA's Federal Register posting, entitled Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Product Labelin...
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    Regulatory Environment Changes Affect REMS

    To maintain the appropriate regulatory strategy for a product, it is important to stay abreast of continuing changes in the regulatory environment and applicable regulatory requirements. Knowing when regulatory requirements have changed because authorities have deemed an alternative to be sufficient to achieve the same goals can reduce wasted effort and costs for sponsors. One US Food and Drug Administration (FDA) requirement that has undergone an important change is th...
  • Sixteen Drugs Identified by AERS as Potentially Having Serious Risks

    Sixteen drugs were identified by the Adverse Event Reporting System (AERS) during the fourth quarter of 2011 and have been flagged by the US Food and Drug Administration (FDA) for further review, the agency said in a statement on its website. The products, which include Fluoroquinolone-based products, Imodium, proton pump inhibitors and Vertex's hepatitis C drug Incivik, were determined to have potential safety issues in FDA's 17 April posting. FDA noted no causal relat...
  • Study: Letters to Doctors Have Varied Impact on Utilization

    A study to be published later today in the journal Medical Care finds that Dear Doctor letters, public health advisories, safety alerts and Black Box REMS warnings have variable impacts on utilization, with some working well and immediately, while others caused delayed reactions or no reactions in the utilization of health care, reports Ed Silverman of PharmaLot . Public health advisories were the most effect forms of communication used by the US Food and Drug Admin...