• 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...
  • Watchdog Group: FDA Failed to Shut Down Compounder Earlier, at Blame for Outbreak of Infections

    What did government officials know, when did they first know it, and what did they do in response? It's a classic question faced by nearly every agency in the US government, including the US Food and Drug Administration (FDA), which has in recent months been under pressure from legislators regarding its oversight of the pharmaceutical compounding industry. In light of a massive outbreak of fungal meningitis that has since been linked to products manufactured at a Massach...
  • 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...
  • Public Citizen Blasts Draft Compounding Rules, Says New Category Would Skirt Regulatory Requirements

    A US Senate proposal to overhaul the way in which compounded pharmaceutical products are regulated is being slammed by a prominent public advocacy group, Public Citizen, which claims that the proposed legislation is "a major step backward for US drug safety." Background In the US, pharmaceutical products generally fall into two categories: Those that are manufactured, typically for use by a wide audience, and those that are specifically tailored for a specific individua...
  • Citing Public Health Needs, FDA Alters Labeling Standards for Smoking Cessation Products

    The US Food and Drug Administration (FDA) has, in response to three citizen petitions submitted to the agency, agreed to modify the labeling of nicotine replacement therapies (NRT) to indicate that consumers are allowed to use other NRTs and infrequently smoke when attempting to quit smoking using an NRT. Background Nicotine replacement products have been on the US market for nearly three decades, and are commonly used to wean users of tobacco products off the substance...