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  • Regulatory NewsRegulatory News

    Researchers Estimate Costs of Exclusivity Extensions to Encourage Antibiotic Development

    A bill introduced last year in the US House of Representatives that would reward manufacturers of certain novel antibiotics with transferrable market exclusivity vouchers could end up costing public and private payers $4.5 billion over 10 years, Harvard Medical School researchers said in an article published Sunday. The economic impact of the bill, which was introduced by Rep. John Shimkus (R-IL), who is not seeking re-election, and co-sponsored by two Democrats, was ...
  • Regulatory NewsRegulatory News

    Will Some Biologics Get 30 Years of Exclusivity?

    As the wrangling over the US-Mexico-Canada trade agreement continues, a provision to require Mexico and Canada to accept 10 years of biologic exclusivity stirred up controversy because it would be two more years than what Canada currently enjoys and add five more years for Mexico. In the US, biologic exclusivity is set at 12 years. But in reality, a 30-year run for a biologic without competition is possible, following a court win for Amgen last August. And 15-plus y...
  • Regulatory NewsRegulatory News

    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...
  • Feature ArticlesFeature Articles

    Marketing Exclusivity for Over-the-Counter Switched Products

    This article discusses the regulatory process for changing a drug's status from "prescription only" to Over-the-Counter (OTC) and discusses issues related to gaining exclusivity for OTC switched products under FDA regulations and guidance and Congressional legislation. Introduction Prior to the enactment in 1951 of the Durham-Humphrey Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) , a pharmaceutical manufacturer could decide whether to market a product...
  • Regulatory NewsRegulatory News

    Amgen Challenge of FDA Decision on Pediatric Exclusivity Could Have Wider Implications

    Back in May, the US Food and Drug Administration (FDA) denied a six-month extension of market exclusivity for Amgen's blockbuster Sensipar (cinacalcet), resulting in lawsuit filed by the drugmaker. A JAMA viewpoint published Wednesday argues that a decision in Amgen's favor could end up diminishing FDA's ability to encourage clinically meaningful pediatric studies. The case centers on the interpretation of how companies "fairly respond" to FDA's written requests ...
  • Regulatory NewsRegulatory News

    Democrats Propose Wide-Ranging Bill to Lower Drug Costs

    More than a dozen House and Senate Democrats late Wednesday unveiled a host of new provisions to bring down the rising cost of pharmaceuticals, offering up many ideas that have been publicly opposed by the pharmaceutical industry. The bill, known as the Improving Access to Affordable Prescription Drugs Act , was introduced alongside a House companion , though neither is likely to gain much traction in the Republican-controlled House and Senate. However, some of the b...
  • Regulatory NewsRegulatory News

    House Bill Would Incentivize Drugmakers to 'Repurpose' Drugs for Rare Diseases

    Rep. Gus Bilirakis (R-FL) on Monday reintroduced a bill that would grant drugmakers an additional six months exclusivity for repurposing already-approved drugs to treat rare diseases. The bill, known as the Orphan Product Extensions Now Accelerating Cures and Treatments (OPEN) Act , was initially included in the 21st Century Cures Act , but was removed before it was signed into law last year. The additional exclusivity for new orphan indications under the OPEN Act w...
  • Regulatory NewsRegulatory News

    180-Day Exclusivity for Generics: FDA Releases Draft Guidance

    The US Food and Drug Administration (FDA) on Thursday put out new draft guidance consisting of 45 questions and answers on the 180 days of exclusivity provided to some generic drugs. Background The statute provides an incentive and a reward to generic drug applicants that expose themselves to the risk of patent litigation. It does so by granting a 180-day period of exclusivity for an abbreviated new drug application (ANDA)  applicant that is first to file a substantial...
  • Regulatory NewsRegulatory News

    FDA’s Approval of a New Abuse-Deterrent Opioid Raises Questions

    The US Food and Drug Administration (FDA) on Monday raised some eyebrows with its approval of another long-acting opioid, Egalet’s Arymo ER (morphine sulfate extended-release tablets), with abuse-deterrent properties. What makes this approval unique is not only the oddly-worded FDA explanation of an another opioid's marketing exclusivity in relation to this approval, but the agency overriding a nearly unanimous advisory panel of outside medical experts. Back in August,...
  • Regulatory NewsRegulatory News

    BIO Opposes House Bill to Reduce Biologics Exclusivity From 12 to 7 Years

    Rep. Jan Schakowsky (D-IL) and three Democratic colleagues in the House took a jab at the biotech industry on Thursday, introducing a new bill that would reduce the amount of exclusivity for biologics from 12 years to seven years. The introduction of the politicized bill comes as President Barack Obama has been pushing to lower the exclusivity threshold since at least 2010, though none of those plans have materialized. However, Obama also supports the Trans-Pacific Partn...
  • Regulatory NewsRegulatory News

    FTC Sues Drugmakers for Not Marketing Authorized Generics

    The Federal Trade Commission (FTC) for the first time ever filed a complaint in federal district court this week alleging that an agreement not to market an authorized generic – often called a “no-AG commitment” – is a form of reverse payment and violates antitrust laws. The complaint alleges that Endo Pharmaceuticals and several other drug companies violated antitrust laws by blocking access to generic versions of the pain drug Opana ER (oxymorphone) and the local anest...
  • Regulatory NewsRegulatory News

    EU High Court Upholds Orphan Exclusivity Ruling

    Earlier this month, the EU's top court upheld a major ruling with implications for orphan drug exclusivity by rejecting an appeal by generic drugmaker Teva Pharmaceuticals Europe. In its appeal, Teva contested the ruling of a lower court that found orphan product exclusivity covers all indications a product is approved for. Background In 2001, Novartis won marketing authorization for its orphan product Glivec (imatinib), marketed as Gleevec in the US, as a first-line t...