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Tag: Scott Gottlieb

  • FDA Issues Warning To Drug Manufacturer Over Product Tampering

    FDA Issues Warning To Drug Manufacturer Over Product Tampering

    McKesson is the first drug manufacturer to get a warning letter from the FDA about properly securing and tracking drug shipments.

    In 2016, three Rite Aid pharmacies reportedly unloaded what were supposed to be bottles of opioid pills, only to discover that the pills had been replaced with other medications such as Aleve.

    Now, partly because of those incidents, the Food and Drug Administration has issued a formal warning to the drug manufacturer McKesson for shipping “illegitimate” opioids and not properly tracking drug shipments. 

    “This is simply unacceptable,” FDA Commissioner Scott Gottlieb said in a statement. 

    Gottlieb said that the FDA has taken measures to curb the flow of illegal drugs into the country. However, the administration also relies on the cooperation of drug manufacturers to ensure the safety of prescription drugs. 

    “Just as critical are the FDA’s efforts to protect patients from exposure to drugs that get into the legitimate U.S. supply chain that may be counterfeit, stolen, contaminated or otherwise harmful, as well as making sure these same drugs aren’t being diverted for illegal sale,” Gottlieb wrote. “Entities within the supply chain must also comply with the law and do their part to respond quickly and thoroughly when notified of potential counterfeit, stolen or diverted products entering the supply chain.”

    Gottlieb said that the warning letter to McKesson is the first issued under the Drug Supply Chain Security Act. 

    “The warning letter to McKesson outlines violations observed during inspections that took place this past summer, including failing to: sufficiently respond to notifications that there was illegitimate product in their supply chain; quarantine and investigate suspect products; and maintain records of investigations of suspect product and disposition of illegitimate product as the law requires,” he wrote. 

    When one pharmacy received medications that had been tampered with, it alerted McKesson to the issue. The distributor launched an investigation, but the FDA said it was not thorough enough. 

    “While McKesson’s internal investigation noted that it was likely the opioid medication was replaced while in their possession or control, McKesson did not sufficiently respond to the notification that they may have distributed illegitimate products,” Gottlieb said. 

    According to CNBC News, McKesson is taking the warning “very seriously.” 

    The company said in a statement, “We have been in communication with the FDA over the past several months to respond to their questions and we are in the process of providing additional procedural detail and documentation, including enhancements recently made in response to the FDA’s initial feedback. We are committed to the security of the supply chain and are taking steps to help ensure we comply fully with FDA’s track-and-trace laws for all pharmaceutical products.”

    View the original article at thefix.com

  • FDA: Limiting Opioids Won't Curb Crisis, Responsible Prescribing Will

    FDA: Limiting Opioids Won't Curb Crisis, Responsible Prescribing Will

    The FDA commissioner issued a statement addressing the stigma aimed at pain patients and the need for providers to take a patient-centric approach.

    Strict opioid prescribing regulations are harming some chronic pain patients, according to U.S. Food and Drug Administration Commissioner Scott Gottlieb.

    On Monday, July 9, the FDA released a statement about its Patient-Focused Drug Development Meeting, during which Gottlieb brought up the struggles some patients face because of strict opioid prescribing laws. 

    According to PatientEngagementHIT, there are some instances in which patients, such as those those facing “metastatic cancer pain management and chronic migraine management,” are best fit for a long-term opioid prescription.

    “Tragically, we know that for some patients, loss of quality of life due to crushing pain has resulted in increased thoughts of or actual suicide,” Gottlieb said in the statement. “This is unacceptable. Reflecting this, even as we seek to curb overprescribing of opioids, we also must make sure that patients with a true medical need for these drugs can access these therapies.”

    While Gottlieb acknowledges that prescribing regulations are necessary in order to fight the opioid crisis, he also says those strategies are negatively affecting patients who rely on the medications for pain management.

    Gottlieb and his colleagues have learned through patient workgroups that patients in need of pain management say they feel stigmatized and have a difficult time building healthy relationships with care providers.

    According to Gottlieb, simply banning opioids or increasing the difficulty of obtaining a prescription is not the solution to the issue. He says instead, better education needs to be available to providers and opioid prescribing should take a “patient-centric” approach, taking patient “preferences, needs, and patient education approaches” into account.

    “Balancing the need to maintain access with the mandate to aggressively confront the addiction crisis starts with good medical management,” Gottlieb said in the statement. “All patients in pain should benefit from the skillful and appropriate care of their pain. It’s also critical that we take this same aggressive approach to changing the culture of medicine around treating pain… Patients in pain deserve thoughtful, careful and tailored approaches to the treatment of their medical conditions.”

    The statement also outlines steps the FDA has taken to push responsible prescribing methods. For example, the FDA released a blueprint for drug manufacturers focusing on how they can educate prescribers. Additionally, the FDA is working with medical professionals to develop resources for clinicians.

    “We need to be mindful of this history, learn from it and make sure that we act aggressively to confront new trends that may continue to fuel the current crisis or lead to a new epidemic of addiction,” Gottlieb explained.

    The FDA also stated that combating the opioid crisis should not involve limiting or banning opioids, but instead has to do with better education about practices.

    “Our goal is to support more rational prescribing practices, as well as identify and encourage development of new treatment options that don’t have the addictive features of opioids,” Gottlieb said in the statement. “In this way, we’ll help ensure that we’re not unnecessarily putting patients as risk of addiction by overprescribing opioids, while also maintaining appropriate access to care for patients with serious pain. In pursuing these goals, we must make sure that patients inform our work.”

    View the original article at thefix.com