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    FDA Issues 53 Product-Specific Guidances to Help With Generic Drug Development

    The US Food and Drug Administration (FDA) on Monday released 53 product-specific guidance documents to aid generic drug development, including 34 new guidance documents, 26 guidances for treatments that lack generic competition and 16 for complex products. When finalized, the guidance documents will represent the current thinking of FDA on, among other things, the product-specific design of bioequivalence studies to support abbreviated new drug applications. Among th...
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    Academics and Researchers Raise Concerns With FDA’s Plan for ‘Integrated Reviews’

    More than 50 academics and researchers from Harvard, Yale, Johns Hopkins and other universities around the world are calling on the US Food and Drug Administration (FDA) to not replace its original reviews of medical products with an “integrated review” because of the valuable information that would be lost. The researchers claimed that such a shift would deprive them of information and data on the clinical studies and trials submitted to FDA, information on the postmar...
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    FDA to Congress: Pediatric Information Lacking in 36% of Relevant Orphan Drug Labels

    In a report to Congress, the US Food and Drug Administration said that there is a public health need for additional pediatric information in labeling for over one-third of approved orphan indications that are relevant in the pediatric population. FDA research, conducted as part of the FDA Reauthorization Act of 2017  (FDARA), found that of all drugs that were approved for an orphan indication between 1 April 1999 and 31 August 2018, a total of 548 orphan indications we...
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    Michigan Senator Raises Concerns With FDA Over High Numbers of Drug Shortages

    As drug shortages continue to increase in the US, Sen. Gary Peters (D-MI) on Wednesday sent a letter to Acting US Food and Drug Administration (FDA) Commissioner Ned Sharpless seeking more information on what FDA will do. Peters, ranking member of the Committee on Homeland Security and Governmental Affairs, called FDA’s current efforts to combat shortages “not sufficient, given the current state of rising drug shortages in our nation.” He also wrote that he’s “increasin...
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    Generic Drug Approvals Hit Another Record High as Competition, Quality Questions Linger

    Another year, another record number of generic drug approvals and tentative approvals for the US Food and Drug Administration (FDA). This has been the story at FDA from FY 2016 to FY 2017 to FY 2018 and now to FY 2019 , with two months to spare. But questions remain on whether these approvals are actually translating into greater competition and lower costs for patients. A report from Pew earlier this year found that the increase in approved generic drugs fr...
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    Senate Coalesces Around Series of Drug Pricing Bills With Little Impact on Pharma Companies

    The Senate Judiciary Committee on Thursday advanced four bills to the Senate floor, three of which were bipartisan, and all meant to lower the prices of prescription drugs. The four bills are part of a coordinated push in the Senate and include a larger bill that advanced Wednesday out of the Senate health committee and is expected to be taken up on the Senate floor before the end of July, and another bill that Sen. Chuck Grassley (R-IA) said he was likely to advance ...
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    FDA Releases New Data to Help Generic Drug Competitors

    Generic drug applicants will now have more information from the US Food and Drug Administration (FDA) when deciding whether to file a generic drug application, which could potentially increase the odds of earlier approvals, the agency said on Tuesday. Previously, FDA’s Paragraph IV Patent Certifications List included only the name of the drug (along with the dosage form and strength) and the date on which the first substantially complete generic drug application that ...
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    700% Price Spike Spurs UK to Allege Four Pharma Companies Agreed to Restrict Competition

    The UK’s Competition and Markets Authority (CMA) on Thursday alleged that Focus Pharmaceuticals, Medreich, Alliance Pharmaceuticals and Lexon have breached UK and EU law by entering into anti-competitive agreements that restricted the supply of the nausea and dizziness drug prochlorperazine. Under two alleged agreements discovered by CMA, Alliance Pharmaceuticals supplied prochlorperazine exclusively to Focus Pharmaceuticals. And Focus paid Lexon a share of the profits ...
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    OPQ Reports on State of Drug Quality in FY2018

    In a report released Monday, the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) provides a look at the pharmaceutical quality landscape for drugs and biologics intended for the US market.   The report itself breaks down different metrics related to product quality and manufacturer compliance with current good manufacturing practice (cGMP) to paint a picture of the overall pharmaceutical quality landscape.   While FDA reports an overa...
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    Industry Seeks Clarity on CGT Draft Guidance

    Pfizer, Perrigo, Teva, Apotex and the Association of Accessible Medicines all sought further clarity from the US Food and Drug Administration (FDA) on draft guidance related to the competitive generic therapy (CGT) designation and CGT exclusivity. The CGT designation is meant to be an incentive for industry to develop generics for drugs that have only one competitor. To date, FDA has granted more than 100 CGT designation requests, and in 2018, between August and Decembe...
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    Health Canada Opens Generic Drug Guidances for Consultation

    Health Canada last week released two draft guidances for public consultation as part of the agency’s effort to clarify the criteria for its abbreviated new drug submission (ANDS) pathway for generic drugs.   Specifically, the draft guidances detail how the agency intends to implement a recently proposed regulatory amendment aimed at boosting access to generic drugs and making labeling more consistent and transparent.   “The draft guidance documents have been releas...
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    Drugmaker Petitions FDA to Revoke Sublocade Orphan Designation

    A citizen petition filed last week by law firm Goodwin Procter on behalf of Pennsylvania-based drugmaker Braeburn calls on the US Food and Drug Administration (FDA) to revoke the orphan designation granted to Indivior’s opioid use disorder treatment Sublocade (buprenorphine extended-release injection).   “Sublocade is not now, nor was it ever a bona fide orphan drug, particularly since more than two million Americans currently are afflicted by opioid addiction,” the pe...