FDA Orders Mail-Back Envelopes For Unused Opioids
Wed, 04/05/2023 - 19:41
The FDA stated that makers of opioid analgesics supplied in outpatient settings must make prepaid mail-back envelopes accessible to outpatient pharmacies and other dispensers as an alternative opioid analgesic disposal option for patients.
The FDA notified all makers of opioid analgesics used in outpatient settings today that they must submit the proposed update to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) within 180 days after receiving the notification letter. The government believes that the updated REMS will be approved in 2024.
When the programme is fully implemented, outpatient pharmacies and other dispensers will be able to obtain prepaid mail-back envelopes from opioid analgesic manufacturers, which they will subsequently be able to offer to patients who have been prescribed opioid analgesics. The REMS update also mandates manufacturers to create patient education materials on safe opioid analgesic disposal, which outpatient pharmacies and other dispensers may also distribute to patients.
This action follows a Federal Register notice filed in April 2022 seeking public comment on a proposed amendment to the OA REMS requiring the distribution of mail-back envelopes and education on safe disposal with opioid analgesics supplied in an outpatient environment.
After surgical procedures, patients frequently report having unused opioid analgesics, and many people obtain opioids through friends or family who have unused opioids. Studies demonstrate that teaching patients about disposal choices may raise the disposal rate of unneeded opioids and that offering a disposal option in addition to education may boost that rate even more.
There are now many mail-back envelope programs in operation in the United States, and mail-back envelopes are commercially available from a variety of sources. The Drug Enforcement Administration and the United States Postal Service have long-standing regulations and policies in place to ensure that mail-back envelopes are unobtrusive, fit for purpose, and can safely and securely transport unused medicines from the patient's home to the location where they will be destroyed.
The FDA is still looking for new ways to promote the safe disposal of unneeded opioid analgesics. The government is specifically investigating whether opioid analgesic makers should also be compelled to make in-home disposal items available to patients who are given opioid analgesics. In order to further evaluate this potential option, the agency will attend the workshop, Defining and Evaluating In-Home Drug Disposal Systems for Opioid Analgesics, hosted by the National Academies of Sciences, Engineering, and Medicine's (NASEM's) Forum on Drug Discovery, Development, and Translation in June 2023. The FDA has also released a Federal Register Notice seeking public input and opinions to help the agency evaluate in-home disposal techniques.
These collaborative projects are part of the FDA Overdose Prevention Framework implementation, which seeks to prevent drug overdoses and reduce deaths through meaningful and creative actions. The FDA continues to respond to all aspects of substance use, misuse, substance use disorders, overdose, and death in the United States through the framework's four priorities, which include: supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing the development of evidence-based treatments for substance use disorders; and protecting the public.
J&J Loses Supreme Court Bid To Stay In Bankruptcy
Mon, 04/03/2023 - 19:55
Despite the firm's planned Supreme Court appeal to use bankruptcy to resolve tens of thousands of cases over its talc products, a U.S. judge stated that a Johnson & Johnson subsidiary cannot delay a court ruling rejecting its bankruptcy.
J&J attempted to use the bankruptcy of its subsidiary firm, LTL Management, to prevent more than 38,000 lawsuits alleging asbestos contamination in the company's baby Powder and other talc products. J&J claims that their consumer talc products are safe and do not contain asbestos.
In January, the 3rd U.S. Circuit Court of Appeals in Philadelphia determined that neither LTL nor J&J had a valid need for bankruptcy protection since they were not in "financial hardship."
LTL sought the 3rd Circuit to stay its verdict until it could file an appeal with the United States Supreme Court. In a brief written ruling, the 3rd Circuit refused that request, instead instructing a U.S. bankruptcy court to dismiss LTL's Chapter 11 lawsuit. LTL has yet to file a formal petition with the United States Supreme Court.
The judge presiding over LTL's bankruptcy case in Trenton, New Jersey, stated that he was willing to dismiss the bankruptcy and continue talc claims once the 3rd Circuit issued a formal mandate of its January ruling, which it has already done.
The bankruptcy of LTL halted a flood of talc lawsuits, including the nearly 38,000 claims consolidated in a New Jersey federal court action. The lawsuits will be reopened after LTL's bankruptcy is over.
According to an attorney representing the official committee of talc claimants in the bankruptcy case, victims of J&J's talc products are now closer to returning to courts and juries of their peers to seek justice and proper recompense. Although LTL battled to keep its bankruptcy, the jury had already permitted one case to be retried.
J&J did not reply quickly to a request for comment. In a court statement, LTL stated that its bankruptcy provides a mechanism to properly and expeditiously settle all talc claims rather than subjecting the business and plaintiffs to "lottery-like results" produced by previous trials.
According to bankruptcy court papers, the corporation faced $3.5 billion in judgments and settlements prior to the bankruptcy filing, including one case in which 22 women were granted a judgment of more than $2 billion.
J&J has won defense victories in 16 trials and appeals that have either reversed or reduced plaintiffs' initial wins in other instances.
J&J said in 2020 that it will end selling its talc Baby Powder in the United States and Canada owing to "misinformation" regarding the product's safety and later revealed its intention to withdraw the product globally in 2023.