• FDA Issues Change to Make it Easier to Submit Citizen Petitions

    It's about to become a lot easier to submit Citizen Petitions to the US Food and Drug Administration (FDA), the agency has announced. The petitions are essentially formal requests made to FDA to take an action-approve a product, declare that a product was not withdrawn from the market for safety reasons, institute a new policy, or even refrain from approving a generic drug product based on potential problems. The wide range of potential uses for the petitions makes them...
  • EU, US Regulators Team up to take on Generic Pharmaceutical Manufacturers

    The US Food and Drug Administration (FDA) has for years struggled with an influx of generic drug applications to the Center for Drug Evaluation and Research (CDER), resulting in a massive backlog that is only just starting to clear thanks to an influx in new user fee funding. But more than just the influx of abbreviated new drug applications (ANDAs), FDA's review resources have been stretched by the fact that many generic drug manufacturers are located outside the US, m...
  • FDA Denies Petition on Guidance for Single Shared REMS, but Agency May Issue in Future

    In May 2013, Prometheus Laboratories submitted to the US Food and Drug Administration (FDA) a citizen petition calling for the establishment of "standards and processes" for single shared Risk Evaluation and Mitigation Strategies (REMS). But in an interesting turn of events, FDA has declined Prometheus' request, saying that while it may issue guidance in the future, it will not be forthcoming at this time. Background In 2007, Prometheus Laboratories purchased Lotronex (...
  • With Competition Close on the Horizon, Suboxone Manufacturer Files Challenge With FDA

    The US Food and Drug Administration (FDA) should not approve the application submitted by a generic competitor to Suboxone (buprenorphine), a drug used to treat opioid addiction, through the 505(b)(2) regulatory pathway, argues a new Citizen Petition filed by law firm Hyman, Phelps & McNamara (HPM). Background Under current regulatory policy, pharmaceutical products generally obtain approval from FDA through three distinct regulatory pathways: New Drug Approval (...
  • Human Rights Group to FDA: Reglan Needs New Restrictions, REMS to Prevent Use at Guantanamo Bay

    The US Food and Drug Administration (FDA) is no stranger to political controversy, with its actions placed under the microscope of legislators and political interest groups on a near-constant basis. But a new Citizen Petition filed by a group of social activists could place the agency at the nexus of an infamous prison allegedly housing some of the world's most dangerous terrorists. The prison in question is the US base at Guantanamo Bay, Cuba, where the US maintains a p...
  • Citizen Petition: Prescription Status of Prosthetics Violates Americans with Disabilities Act

    Can an approved medical device be set up in such a way that it breaks federal law? That's the question behind a new Citizen Petition filed on 26 August 2013 with the US Food and Drug Administration (FDA), which argues that exclusive servicing agreements for prosthetic devices break the Americans With Disabilities Act (ADA) by discriminating against amputees who are held hostage to high fees and a lack of competitive pricing. The petition, authored on behalf of a privat...
  • Group to FDA: Use Enforcement Discretion to Allow Pediatric Labeling Updates on OTC Tylenol

    A new Citizen Petition filed with the US Food and Drug Administration (FDA) by the Consumer Healthcare Products Association (CHPA) seeks to allow additional information to be placed on over-the-counter (OTC) acetaminophen products with the intent of making it easier to give accurate doses to young children. Background Children have been a historically under-represented population in drug trials, largely due to ethical conundrums. Many companies first seek approval for a...
  • FDA Finalizes Decision Permitting Sale of Non-Abuse-Resistant Copies of Opana ER

    The US Food and Drug Administration (FDA) has finalized a decision made earlier this year granting generic pharmaceutical companies the right to introduce generic variants of Endo Health Solution's Opana ER, saying that it found that the products had not been removed from the market for reasons of safety or efficacy. Background: A Long and Complicated History Opana ER (oxymorphone hydrochloride) is an opioid painkiller that first obtained approval from FDA in June 2006 ...
  • Asthma Patient Group Petitions FDA to Keep Products out of Novel OTC Switch Paradigm

    The US Food and Drug Administration (FDA) has had a contentious relationship with over-the-counter products (OTC) in recent years. While a considerable amount of attention has been paid to a lengthy episode involving the birth control drug levonorgestrel and what age groups are cleared to access it, less attention has been spent on a product that is arguably even more important: asthma inhalers. Background In March 2012, FDA announced it would start to unveil a new "par...
  • Citizen Petition Claims Lab-Developed Tests aren't Devices and are Beyond FDA Regulation

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg recently announced that her agency would soon end a long-standing policy of enforcement discretion toward a classification of diagnostic devices known as laboratory-developed tests (LDTS), but now at least one association has filed a Citizen Petition with the agency seeking to exempt LDTs from new guidance, new regulation or seemingly any regulation whatsoever. Background Under normal circumstances, med...
  • Prometheus Slams FDA for Lack of REMS Clarity as Agency Shows Signs of Conceding

    A Citizen Petition filed by Prometheus Laboratories in May 2013 slams the US Food and Drug Administration (FDA) for failing to establish "standards and processes" for single shared Risk Evaluation and Mitigation Strategies (REMS), explaining that the current process is unprecedented, unclear and potentially raises anti-trust issues that could leave companies open to litigation. Background In 2007, Prometheus Laboratories purchased Lotronex (alosetron hydrochloride), a t...
  • 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...