• Regulatory NewsRegulatory News

    What Drugs Really Cost: GAO Wants CMS to Find Out

    In order to help ensure the accuracy of Medicare Part B drug payment rates, the US Government Accountability Office (GAO) on Monday urged Congress to require all manufacturers of Part B drugs paid at average sales price (ASP) to submit sales price data to the Centers for Medicare & Medicaid Services (CMS). What’s more, GAO is calling on Congress to ensure that CMS has the authority to request source documentation to periodically validate drug companies’ pricing data, wh...
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    FDA Draft Guidance to Assist CMS With IDE Coverage Decisions

    The US Food and Drug Administration (FDA) on Tuesday released new draft guidance to clarify difficulties in categorizing investigational medical devices for Medicare coverage, just two days before a memorandum of understanding is set to take effect between FDA and the Centers for Medicare and Medicaid Services (CMS). While an agreement has been in place between the two agencies for more than two decades, FDA says it has run into issues with some devices not easily fittin...
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    FDA Proposes New Databases to Monitor CAR T-Cell Safety Across INDs

    The US Food and Drug Administration (FDA) wants to create two new databases that will allow it to look at safety and manufacturing information across multiple applications for products within a promising class of cancer immunotherapies called anti-CD19 CAR modified T-cells. FDA officials presented their proposal to pilot the databases last week during a meeting of the Recombinant DNA Advisory Committee (RAC), which is organized by the National Institutes of Health's (NIH...
  • Feature ArticlesFeature Articles

    Agency Meetings with the US Food and Drug Administration

    Informational guidance meetings with representatives from the US Food and Drug Administration (FDA) have been part of the original Prescription Drug User Fee Act ( PDUFA ) and were included in the PDUFA reauthorization in 2012. 1 A second revision of the FDA guidance document for these meetings was released as a draft for comments in March 2015. This new draft guidance updates the meeting instructions and incorporates changes resulting from the Food and Drug Adminis...
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    FDA to Require Electronic Submission of New Drug, Biologic Files in Next Two Years

    Within two years, the US Food and Drug Administration (FDA) will require all new drug and biological product submissions to be sent electronically, the regulator announced this week. Background FDA has received electronic submissions from drug companies since at least 2003, when it adopted the International Conference on Harmonisation's (ICH) electronic common technical document (eCTD). The submission standard is used by many of the world's top regulatory bodies, incl...
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    An Increasing Number of Companies Are Using a Once-Obscure FDA Drug Approval Pathway

    Companies are increasingly using a lesser-known regulatory pathway to get new doses, formulations or combinations of drugs approved by the US Food and Drug Administration (FDA), a review by Thompson Reuters has found. Background In the US, pharmaceutical products are in general approved in one of three ways: A drug never before approved by FDA for a specific condition is approved using a New Drug Application (NDA) through the 505(b)(1) pathway A generic drug refere...
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    Meeting With FDA? Here's What Regulators do (and Don't) Want from Drug Companies

    A new guidance document issued by the US Food and Drug Administration (FDA) is meant to outline the agency's expectations for meetings that take place between FDA and a sponsor before and after the submission of a new chemical or biological drug product. Background Since the passage of the original Prescription Drug User Fee Act (PDUFA) in 1992, the pharmaceutical and biopharmaceutical industries have helped to fund the operations of FDA through payments of so-called ...
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    FDA Cracking Down on Attempts to Delay Entry of Generic Drugs, Data Show

    A new report issued by the US Food and Drug Administration (FDA) on the use of petitions meant to delay or prevent the entry of new generic drugs shows that the agency is denying those petitions in record numbers, even as regulators say its authority to dispose of them more easily is lacking. Background FDA, like any other federal agency, takes actions in response to a wide range of factors. It may, for example, implement a new policy at the explicit direction of ...
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    EMA Review of Emergency Contraceptives Short on Data, but Finds no Cause for Concern

    EU regulators say that two emergency contraceptive drugs, levonorgestrel and ulipristal, remain effective for their prescribed purpose "regardless of bodyweight," placating some—but not all—concerns that the drugs might lose effectiveness when taken by women weighing more than 80kg (176 lbs). Background In November 2013, Mother Jones broke the news that HRA Pharma, manufacturer of the emergency contraceptive Norlevo, a levonorgestrel-based emergency contraceptive, w...
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    Senators Say FDA Import Regulation Would Harm Vulnerable Consumers

    • 10 July 2014
    Four US senators are pressuring the US Food and Drug Administration (FDA) to walk back a rule proposed by the agency in May 2014 that would make it more difficult to import unapproved drugs into the US. Background The proposed rule, Administrative Destruction of Certain Drugs Refused Admission to the United States , is meant to tweak the agency's pharmaceutical import provisions under Section 801(b) of the Federal Food, Drug and Cosmetic Act (FD&C Act) . Under the ...
  • As GSK Recalls Weight Loss Drug After Tampering, A Focus on Limits of the DQSA

    Did legislators go far enough in their attempts to secure the pharmaceutical supply chain when passing the Drug Quality and Security Act (DQSA) last year? That question is now on the minds of some after pharmaceutical manufacturer GlaxoSmithKline issued a massive recall of all lots of its over-the-counter weight loss drug Alli (orlistat capsules) following a determination that some lots of the drug had been " tampered with ." While the DQSA contains extensive requir...
  • Health Officials' Plan B Debacle Comes Back to Haunt Regulatory Process Once Again

    Under normal regulatory procedures in the US, when a new drug is approved by the US Food and Drug Administration (FDA), its approval decision is the last word. But now in the wake of the agency's approval of a painkiller that critics say is dangerous, one senator is calling for US health officials to exercise a rarely used authority to overturn the decision. Background: Plan B Until December 2011, FDA had never before seen one of its decisions overturned. But shortly af...