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Tag: Food and Drug Administration

  • FDA Considers Limiting Outpatient Opioid Prescriptions

    FDA Considers Limiting Outpatient Opioid Prescriptions

    The FDA is taking feedback from the public as it weighs the decision to reduce high-dose prescription painkillers delivered in outpatient settings. 

    Advisors for the Food and Drug Administration (FDA) met last week to discuss a possible cap on high-dose opioids delivered in an outpatient setting, a move that is intended to reduce the risk of addiction and dependency. 

    According to MedPage Today, the meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesia Drug Products Advisory Committee included presentations by doctors, and discussions by policymakers. 

    In a memorandum released ahead of the meeting, advisors for the FDA said that the conference aims to address dual concerns. 

    “When considering regulatory strategies relating to opioid analgesics, FDA always considers two fundamental public health goals: 1. We want to reduce opioid misuse, abuse, addiction, overdoses and deaths. 2. We want to ensure that products are available to meet the medical needs of people living with debilitating pain,” the memo read. 

    “We are also interested in discussing the magnitude and frequency of harms associated with higher doses of opioid analgesics relative to lower doses, as well as optimal strategies for managing these risks while ensuring access to appropriate pain management for patients,” Judy Staffa, associate director for the Public Health Initiatives Office of Surveillance and Epidemiology at the Center for Drug Evaluation and Research (CDER), wrote in the memorandum that was sent to conference attendees. 

    Restricting highly addictive high-dose opioids while also meeting the needs of patients with chronic pain has been a delicate balancing act that many people feel has not been addressed well by federal regulators. The meeting last week was an attempt to continue discussions about how best to serve both needs. 

    “There is a strong need to bring together the community of stakeholders to consider the collective scientific understanding of the issues relating to higher daily doses and higher dosage strength opioid analgesic products and potential strategies to reduce risks to patient and public health,” Staffa wrote. 

    Dr. Ning Hu, medical officer of the CDER’s Division of Anesthesia, Analgesia, and Addiction Products, said that high-dose opioids are dangerous, but so is uncontrolled pain, which—in the most severe cases—can cause people to consider suicide.

    Many prescribers followed the CDC’s 2016 guidelines for prescribing opioids, but those were interpreted too drastically, Hu wrote. 

    “The guidelines were misinterpreted and misapplied, contributing to substantial harms to patients, particularly patients with chronic pain who were forced to taper their previously stable opioid doses to lower doses, or who were forced to discontinue their opioids through forced tapers or patient abandonment,” Hu wrote. 

    In addition to the discussions happening at the conference, the FDA has opened public comment on the issue of high-dose opioids. Public comment will remain open through June 30, and is available here. 

    View the original article at thefix.com

  • FDA Admits Past Mistakes In Handling Opioid Crisis

    FDA Admits Past Mistakes In Handling Opioid Crisis

    The Food and Drug Administration addressed its missteps in handling the crisis and outlined its future plans in a new statement.

    FDA Commissioner Scott Gottlieb issued a far-ranging statement about his agency’s most recent and upcoming actions, while also addressing past missteps, in regard to the national opioid epidemic.

    Noting that the FDA’s previous wait-and-see policy in regard to evidence and intervention left it “a step behind a crisis that was evolving quickly,” Gottlieb said in the statement that his agency will implement more effective measures to reduce exposure to opioids, including prescription and labeling changes, promotion of treatment therapies, and approval of non-dependency-forming pain treatment.

    Calling the opioid crisis “a top priority” of both Secretary of Health and Human Services Alex Azar and the Trump Administration as a whole, Gottlieb wrote that faster and more decisive action will define the FDA’s policy in 2019.

    The rise in synthetic opioids like fentanyl and the “continued prevalence” of opioid prescriptions with overly long durations has prompted the agency to “step up its intervention,” according to Gottlieb.

    The commissioner also noted that the FDA’s previous approach—”waiting for the accumulation of definitive evidence of harm” put them in a position of catching up to the crisis as it ravaged “vulnerable communities.”

    “We don’t want to look back five years from now, at an even bigger crisis, with regret that there were more aggressive steps that we could have taken sooner,” wrote Gottlieb. “All options are on the table.”

    As Gottlieb outlined in his statement, these options have included expanded information on drug labeling. Passage of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act in October 2018 has also given the agency new authority to assess and reduce dependency and misuse of opioids, including requirements for packaging on opioids and other drugs that carry a high risk of abuse or overdose.

    According to the statement, FDA will issue a report on their recommendations for prescription guidelines at the end of 2019.

    The FDA is also considering an option to require certain immediate-release formulations of opioids be made available in blister packages containing one- and two-day dosages, which would “comport with evidence demonstrating that a day or two of medication is sufficient” and could “reduce the overall amount of dispensed drugs available for misuse, abuse and diversion.”

    Gottlieb also wrote that the agency will consider a formal evaluation of prospective opioid drugs to determine its application for specific patients, and whether or not the newer application is safer or more effective for treatment than existing, non-addictive medication. The Risk Evaluation and Mitigation Strategies (REMS) program, which measures the benefits of a particular drug over its potential risks, will also be subject to review to determine if it is properly addressing such concerns.

    The FDA will also prioritize the development of new and effective forms of medication-assisted treatment (MAT) to treat opioid dependency and non-addictive pain medication, and expand access to the overdose reversal drug naloxone.

    The agency will also continue to partner with U.S. Customs and Border Protection to reduce the marketing and distribution of illegal opioids through national borders and through international shipping.

    View the original article at thefix.com

  • Former Commissioner Blames FDA For Opioid Crisis: "No One Stopped It"

    Former Commissioner Blames FDA For Opioid Crisis: "No One Stopped It"

    “There are no studies on the safety or efficacy of opioids for long-term use,” said former FDA commissioner David Kessler in a recent “60 Minutes” interview.

    The former Food and Drug Administration commissioner expressed regret that the agency allowed drug companies to promote the idea that opioid painkillers were safe for long-term use in a recent 60 Minutes interview.

    Dr. David Kessler was FDA commissioner during the ’90s, when Purdue Pharma’s prescription opioid OxyContin was approved. Shortly after, Purdue began an aggressive marketing campaign to both prescribers and consumers, including chronic pain patients. 

    In 2001, the FDA changed the indication on the label for prescription opioids to say that it was safe for long-term use, allowing drug companies to market them as such. However, Dr. Kessler now says that there were no studies on the long-term effects of regular, ongoing opioid use at the time.

    “There are no studies on the safety or efficacy of opioids for long-term use,” said Kessler in the interview. “The rigorous kind of scientific research the agency should be relying on is not there.”

    The former commissioner also appears to regret allowing the methods of the OxyContin marketing campaign, which were unprecedented in the prescription drug market. Soon, companies like Purdue were convincing doctors to prescribe more pills at higher doses — something that experts believe fueled the current epidemic of opioid-related addiction and overdoses.

    Dr. Kessler is now on retainer by cities and counties that are suing Perdue Pharma and other drug companies for the damage caused by the opioid crisis. He officially left the FDA before the drugs were proclaimed safe for extended use, but laments that no one stopped it from happening.

    “You have a system of pharmaceutical promotion that changed the way medicine practiced and no one, all right, stopped it,” he said. He later blames this on understaffing in the FDA marketing department.

    Current FDA Commissioner Dr. Scott Gottlieb declined to be interviewed, instead providing a written statement.

    “Many mistakes were made along the way,” it reads. “While the agency followed the law in approving and regulating opioids, we at the FDA include ourselves among those that should have acted sooner.”

    On another 60 Minutes segment three days later, drug manufacturer Ed Thompson indicted “his own industry” and agreed with Dr. Kessler’s assessment that the label change was what sparked the opioid epidemic.

    “The root cause of this epidemic is the FDA’s illegal approval of opioids for the treatment of chronic pain,” Thompson said. “Without question, they start the fire.”

    Thompson himself is now suing the FDA in an attempt to force the administration to change the label on prescription opioids once again to say that it’s only safe for short-term use. As a maker of these drugs, he stands to lose billions if he’s successful. Thompson is going ahead with the suit, however, refusing to sell what he calls “snake oil” to consumers.

    “You’re using high-dose, long-duration opioids when they’ve never been designed to do that,” he explained to the 60 Minutes host. “There’s no evidence that they’re effective. There’s extreme evidence of harms and deaths when you use them.”

    View the original article at thefix.com

  • FDA Has "Cozy Relationship" With Pharmaceutical Companies, Says Adviser

    FDA Has "Cozy Relationship" With Pharmaceutical Companies, Says Adviser

    “The FDA has a lack of transparency. They use the advisory committees as cover,” said the head of the FDA’s opioid advisory council. 

    A Food and Drug Administration adviser says that the agency is putting the needs of pharmaceutical companies above the public by continuing to approve dangerous pain medications. 

    Speaking with The Guardian, Dr. Raeford Brown, head of the FDA’s opioid advisory council, said there are “cozy, cozy relationships between the pharmaceutical industry and various parts of the FDA.”

    Brown has been vocally opposed to the approval of the drug Dsuvia, an opioid more powerful than fentanyl that the FDA recently approved against the recommendation of the advisory committee. (The FDA is not bound by the recommendation of the committee.)

    Brown said that the committee voted to approve the drug while many committee members were away at a professional conference, which he believes was a willful manipulation of the system. 

    “There’s no question in my mind right that they did that on purpose. The FDA has a lack of transparency. They use the advisory committees as cover,” Brown said. 

    He pointed to Dsuvia’s approval as the latest sign that the FDA has allegiances to pharmaceutical companies. 

    He said, “I think that the FDA has learned nothing. The modus operandi of the agency is that they talk a good game and then nothing happens. Working directly with the agency for the last five years, as I sit and listen to them in meetings, all I can think about is the clock ticking and how many people are dying every moment that they’re not doing anything. The lack of insight that continues to be exhibited by the agency is in many ways a willful blindness that borders on the criminal.”

    This approach is fueling the rise in opioid-related deaths, he said. 

    “They should stop considering any new opioid evaluation. For every day and every week and every month that the FDA don’t do the right thing, people drop dead on the streets. What they do has a direct impact on the mortality rate from opioids in this country.”

    Brown pointed out that the FDA relies on pharmaceutical funding for 75% of the budget of the division that approves opioid medication. He explained that this allows pharmaceutical companies to unfairly influence the process, something that the FDA denies. Brown worries that despite the widespread deaths caused by the opioid epidemic and the resulting media coverage, little will change at the FDA.

    “Nothing is fundamentally being done to effect change in the regulation of opioids,” he said. “If the FDA continues to encourage the pharmaceutical industry to turn out opioid after opioid after opioid, and the regulation of those opioids is no better than it was in 1995, then we’ll be cleaning this up for a long time.”

    View the original article at thefix.com

  • FDA Cracks Down On Top E-Cig Brands To Curb Teen Vaping Epidemic

    FDA Cracks Down On Top E-Cig Brands To Curb Teen Vaping Epidemic

    Around 1,300 warning letters have been sent to retailers of e-cigarettes found to be illegally selling e-cigarette products to minors.

    The Food and Drug Administration, concerned about the rising numbers of teenagers who “vape,” is cracking down on major e-cigarette brands to try and stop this trend.

    In a press release issued on Wednesday (Sept. 12), the FDA announced that it is requesting major brands—JUUL, Vuse, MarkTen, Blu, and Logic—to submit plans to “immediately and substantially reverse these trends” of young people vaping.

    If they do not comply within 60 days, the agency “may require the companies to revise their sales and marketing practices, to stop distributing products to retailers who sell to kids and to stop selling some or all of their flavored e-cigarette products until they clear the application process,” according to CNBC.

    The latest crackdown is the result of a nationwide undercover sweep over the summer. Since then, 1,300 warning letters have been sent to retailers of e-cigarettes found to be illegally selling e-cigarette products to minors.

    The vast majority of the violations were for the illegal sale of JUUL, Vuse, MarkTen, Blu and Logic—which account for over 97% of the U.S. e-cigarette market.

    Initially, e-cigarettes were touted as a less harmful alternative to traditional cigarettes for people who want to quit. But growing use among young people is now a concern for the FDA.

    “In enabling a path for e-cigarettes to offer a potentially lower-risk alternative for adult smokers, we won’t allow the current trends in youth access and use to continue, even if it means putting limits in place that reduce adult uptake of these products,” said FDA Commissioner Scott Gottlieb in the press release.

    “We see clear signs that youth use of electronic cigarettes has reached an epidemic proportion, and we must adjust certain aspects of our comprehensive strategy to stem this clear and present danger,” Gottlieb declared, going on to say that promoting smoking cessation can’t come “at the expense of kids.”

    “We cannot allow a whole new generation to become addicted to nicotine,” he added.

    In the coming weeks, the FDA said it will take additional action under its Youth Tobacco Prevention Plan, and ramp up enforcement of the illegal sale of these products to kids.

    View the original article at thefix.com

  • FDA Challenges Developers To Make Better Pain Treatment Devices

    FDA Challenges Developers To Make Better Pain Treatment Devices

    For an innovation challenge, the FDA is looking for devices that provide more benefits than opioids, with fewer risks. 

    The Food and Drug Administration wants better options available for treating pain—and it is turning to developers for help. 

    The FDA announced this week that it is running a new innovation challenge for medical devices that provide solutions to detecting, treating and preventing addiction, addressing drug diversion and treating pain.

    Applications will be accepted through September, and the developers of devices that are chosen will be able to work closely with the FDA to bring their product to market. 

    “Medical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in tackling the opioid crisis. We must advance new ways to find tools to help address the human and financial toll of opioid addiction,” said FDA Commissioner Scott Gottlieb, M.D. 

    Gottlieb hopes that by encouraging the development of medical devices, fewer patients will need to rely on opioid pain relief, which has a high risk of addiction. 

    “For example, better medical devices that can effectively address local pain syndromes can, in some cases, supplant the use of systemic opioids. This can help reduce overall use of opioids,” he said. 

    Finding replacements for opioids is an important piece of confronting the opioid epidemic, he added. 

    “This innovation challenge is an example of the FDA’s commitment to an all-of-the-above approach to confront the opioid epidemic, including helping those currently addicted to opioids and preventing new cases of addiction,” he said. “We’re hopeful that in collaborating with public health-minded innovators, we can identify and accelerate the development of new technologies, whether a device, diagnostic test, mobile medical app, or even new clinical decision support software, that can contribute in novel and effective ways to help reduce the scope of this crisis.”

    Developers can submit devices that are in any stage of development, including the concept phase. The FDA will be looking for devices that provide more benefits than opioids, with fewer risks. 

    In 2012, the FDA ran a similar innovation challenge that helped develop and bring to market new ways of treating renal disease, said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. He hopes this challenge will have similar results. 

    “The FDA stands ready to provide significant assistance and expedite premarket review of applications to help bring innovative devices that, if properly instituted, could help those at risk for addiction or treat those who might develop opioid use disorder,” he said. “We also hope that in turn these novel products may also help pave the way for the development of future products that build on the latest technologies.”

    View the original article at thefix.com