• Regulatory NewsRegulatory News

    Supreme Court Declines to Hear Case on Off-Label Prescribing Authority

    The US Supreme Court has refused to hear a challenge to an Arizona law that sought to limit the use of an abortion drug, avoiding a potential showdown over whether off-label prescribing is explicitly allowed under federal law, or simply tolerated. Background As Regulatory Focus has previously reported , the Supreme Court had been petitioned to hear an appeal of the federal court case  Planned Parenthood v. Humble —a case challenging a 2012 Arizona law which makes i...
  • Regulatory NewsRegulatory News

    Off-Label Use Case on Potential Path to Supreme Court, With Wide-Ranging Implications for FDA

    A debate in Arizona which in part focuses on the authority of the US Food and Drug Administration (FDA) to regulate the use of drug products may soon find its way before the Supreme Court, with major implications for a wide range of products. Background The matter in question concerns a federal court case, Planned Parenthood v. Humble , challenging a 2012 Arizona law which makes it illegal to use the drug RU-486 (mifepristone) for uses not explicitly approved by FDA....
  • Regulatory NewsRegulatory News

    CDRH Finalizes Appeals Process Guidance, Adding New 'Significant Decision' Category

    The US Food and Drug Administration (FDA) this week released a final version of a guidance on the Center for Devices and Radiological Health's (CDRH) appeals process. Background The 2013 passage of the Food and Drug Administration Safety and Innovation Act ( FDASIA ) instituted a new provision under Section 603 of the act intended to overhaul how FDA's medical device regulatory division, CDRH, handles appeals. Section 603 amended Section 517A of the Federal Food...
  • Regulatory NewsRegulatory News

    FDA Attitude on Off-Label Prescribing Central to Arizona Abortion Drug Access Case

    A federal court has ruled that Arizona's attempts to limit access to an abortion drug known as RU-486 (mifepristone) are unconstitutional, drawing on the US Food and Drug Administration's (FDA) authority to support its ruling. Background The case involved Arizona's attempts to restrict the use of RU-486, which is approved by FDA for use in terminating pregnancy within 49 days of the start of a woman's last menstrual period. As FDA explains on its website , the ...
  • Advocacy Group Pries Additional Details from FDA About Approval of AIDS Drug Truvada

    The AIDS Healthcare Foundation (AHF), a DC-based advocacy group, has won yet another legal battle against the US Food and Drug Administration (FDA), forcing it to turn over significant documents related to the approval of Gilead Science's pre-exposure prophylaxis (PrEP) drug Truvada (tenofovir/ emtricitabine). Background The legal victory for AHF is its second in the last year. In 2013, FDA announced it would expedite the review of Truvada based on its expected cl...
  • China's FDA Announces New Administrative Review Process

    China's FDA (CFDA) issued a notice on 6 November 2013 establishing a new administrative review process to take effect as of 1 January 2014 allowing entities to appeal decisions. A requested review must allege that the specific administrative acts infringe upon the legitimate rights and interests of citizens, legal persons or other entities. The burden will be on the applicant to establish the factual and legal basis for the reconsideration of a specific administrative ...
  • Supreme Court Again Rules in Favor of Generic Pharmaceutical Industry, Supports Federal Preemption

    The current term of the US Supreme Court has already been a momentous one for the life sciences industry, having declared patents on naturally-occurring DNA invalid and legal settlement agreements commonly known as "pay for delay" agreements potentially illegal under federal competition law. Now the court has released a third potentially landmark decision, Mutual Pharmaceutical Co. v. Bartlett , in which the justices have decided that when it comes to so-called "failur...
  • BREAKING: Supreme Court Rules Naturally Occurring DNA is Not Patentable

    In a landmark decision, the Supreme Court has decided in favor of the Association for Molecular Pathology in its case against Myriad Genetics, ruling that naturally occurring DNA is not patentable, while synthetic DNA is. Background The case, heard in April 2013, concerned patents held on two genes, BRCA 1 and BRCA2, which are closely linked to a woman's risk of breast and ovarian cancer. Myriad Genetics, a biotechnology company, owned the patent rights to the use of th...
  • Long-Awaited Guidance on CDRH's Appeals Process Released, Alleviating Some Industry Concerns

    The US Food and Drug Administration (FDA) has released two long-awaited guidance documents regarding the appeals process to be used by medical device manufacturers that have received a rejection by the agency. Background FDA has been working to revamp its appeals process for several years now. Starting in late 2011, the Center for Devices and Radiological Health-the center that reviews most medical device applications-released the draft of its CDRH Appeals Process gui...
  • Preview: Supreme Court Could Determine Biotechnology Industry's Future

    Depending upon whom you ask, a case to be heard by the US Supreme Court on Monday will either mark a massive blow to the biotechnology industry and its regulated products or a massive blow to the practice of science, including the ability to use a genetic marker to determine the best course of treatment for a patient. Regardless of the veracity of either side's claim, one thing is clear: the case of Association for Molecular Pathology, et al vs. Myriad Genetics will be ...
  • In Landmark Ruling, Court Sees Off-Label Marketing as Protected Free Speech

    • 04 December 2012
    In a potentially landmark ruling, the US 2 nd Circuit Court of Appeals has reversed a lower court's finding that a pharmaceutical sales representative was guilty of promoting off-label uses for certain approved drug products, finding that the government's actions had violation the man's right to free speech. Many analysts questioned whether the ruling could eventually lead to a sea change in the way drug promotion is conducted in the US. Currently, companies are not a...
  • Feature ArticlesFeature Articles

    Demystifying the FDA Appeals Process

    For more than a decade, there has been confusion about the appeals process at the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). There are several avenues to file an appeal, each with specific requirements. This article aims to clarify the CDRH appeals process so stakeholders can use it effectively. The relevant processes for FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research ...