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  • Regulatory NewsRegulatory News

    New California Laws Set Sights on Pay-for-Delay Agreements, HIV Prevention

    California Gov. Gavin Newsom (D) on Monday signed into law one bill that aims to crack down on pay-for-delay deals that can block the launch of generic drug competition and one bill that will allow pharmacists, under specific circumstances, to distribute limited supplies of HIV drugs without prescriptions. California’s new pay-for-delay law is the first in the nation directed at the deals between pharmaceutical companies in which one company pays a competitor to delay r...
  • Regulatory NewsRegulatory News

    California Governor Vetoes Right-to-Try Bill, Points to FDA Compassionate Use Program

    California Gov. Jerry Brown (D) on Sunday vetoed a bill that would've allowed a pharmaceutical company to make an investigational drug available to a patient with a terminal illness on the recommendation of two physicians. Brown explained in a message with his decision that the so-called "Right to Try" (RTT) legislation is intended to help patients with life-threatening conditions, and in some cases these patients can already gain access to experimental treatments under ...
  • RAPS' LatestRAPS' Latest

    RAPS to Host San Jose Career Fair

    On 10 September, RAPS will host a career fair and networking event for regulatory job seekers and employers in the San Jose area. The event will be held from 5:30 to 8:30 pm PDT at the Biltmore Hotel & Suites in Santa Clara, CA, and will give attendees a chance to network and meet in person to discuss open regulatory positions and career opportunities. The career fair is free for job seekers to attend. To register, fill out this online form . Employers int...
  • As FDA Considers First Wave of Biosimilar Drugs, Are States Limiting Their Eventual Impact?

    • 05 September 2013
    • By
    One of the biggest changes to food and drug law changes by the 2010 passage of the Patient Protection and Affordable Care Act (PPACA), better known by most as Obamacare, was its provisions for the creation of a "biosimilars" pathway under Section XII of the law. But now one of the most influential states in the US is moving to restrict their eventual use, conceding arguments made by innovative biopharmaceutical manufacturers that physicians should be able to restrict th...
  • California County to Pharmaceutical Manufacturers: Pay Up

    • 25 July 2012
    • By
    Representatives of Alameda County in California have voted to require pharmaceutical companies to assume the cost of disposing of unused medicinal products, reports The Associated Press. On Tuesday, 25 July the Alameda County Board of Supervisors voted to unanimously pass an ordinance aimed at requiring the industry to "dispose of expired and unused prescription drugs." The AP reports the legislation is the first of its kind in the US, and was passed in response to the B...
  • California Supreme Court Looks to Take Up 'Pay for Delay' Case

    The California Supreme Court is set to review a case on so-called 'pay for delay' settlements that see pharmaceutical manufacturers pay generic manufacturers to secure additional months of market exclusivity for their products. The court will review a decade-old class-action lawsuit against Bayer over its pay for delay settlement to Barr Laboratories. Barr was reportedly planning to sell a generic version of Bayer's antibiotic, Cipro (ciprofloxacin). The lawsuit alleges...
  • 30 Tons of Unused Drugs Left At Sites

    • 02 March 2012
    • By
    Alameda County, CA, is ready to pass a law requiring pharmaceutical companies pay for disposal of unused drugs. More than 30 tons of unused pharmaceuticals were found at sites in the San Francisco Bay area, and the county is concerned about those drugs getting into the wrong hands or ending up in the water supply, according to a report by Fierce Pharma Manufacturing . The new law would make companies financially responsible for a disposal program run by the county's en...
  • New Bill Looks to Streamline Inspections

    A new bill introduced by Representative Brian Bilbray (R-CA) would rein in regulatory overlap by preventing states from "requiring duplicative inspections" of manufacturing plants. Bilbray's bill, the Science and Technology Regulatory Relief Act of 2012 (H.R. 4044) , prevents states from requiring US Food and Drug Administration-inspected manufacturers to undergo a state-sanctioned inspection. Exceptions are provided if the state receives complaints of unsafe produ...