FDA seeks to find the right balance for opioid access

While the FDA is under increasing pressure to deal with the opioid crisis, patients across the United States have shared their views on how federal and federal actions have hindered the development of opioids. 39; access to pain medication.

The FDA meeting was aimed at getting patients' views on the daily impact of chronic pain to inform clinical trials, and coinciding with a demand for greater use of self-reported results and the development of patient-centered drugs
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The public record on patient-centered drug development for chronic pain – opened when the meeting was announced in May – has already received 973 comments. Dr. Sepideh Haghpanah of the FDA said at the meeting that the agency will publish a summary of the comments received.

Group discussions pointed out that the consequences of the conversation around the opioid epidemic in the United States were largely focused on minimizing prescriptions, despite previous hurdles in the past. 39, access for legitimate patients.

Patients asked the FDA to tell the public "the truth" about prescription opioids, claiming that they are generally safe and effective for both short- and long-term use.

One of the barriers to obtaining pain medications is related to prescription guidelines developed by the United States Centers for Disease Control and Prevention (CDC). "No one will take charge of another doctor's prescription" because of the paperwork that the FDA and the CDC requires, a patient said.

Other patients have highlighted another obstacle to the management of chronic pain approved by the FDA – the badociated side effects. For example, a patient with rheumatoid arthritis and osteoarthritis opted for opioids rather than for NSAIDs. This is because opioids have helped to improve the quality of life whereas an NSAID such as naproxen can cause a number of side effects like tachycardia and hypertension, according to the patients.

These real-life stories underscored the need to strike the right balance between preventing opioid abuse / abuse and protecting "legitimate patients" in the fight against "the many facets of this complex crisis." of public health, "said Scott Gottlieb, FDA Commissioner. in a statement issued Monday.

The goal of the FDA is to "support more rational prescribing practices, as well as to identify and encourage the development of new treatment options that do not have the addictive characteristics of opioids, "said Gottlieb. "In this way, we will help not unnecessarily expose patients to the risk of addiction by prescribing opioids, while maintaining appropriate access to care for patients with severe pain." He added that patient involvement is essential to pursue them. goals.

Last month, the agency issued a draft directive on the development of patient-centered drugs, further encouraging the integration of patient input into drug development programs.