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FDA Seeks to Strike the Right Balance on Opioid Access

Posted 09 July 2018 | By Ana Mulero 

FDA Seeks to Strike the Right Balance on Opioid Access

As the US Food and Drug Administration (FDA) comes increasingly under pressure to address the nation’s opioid crisis, patients across the US shared their perspectives on how state and federal actions have hindered access to pain relief medication during a meeting Monday.
 
FDA’s meeting aimed to obtain patient input on the daily impact of chronic pain to inform clinical trials, and coinciding with a push for greater use of self-reported outcomes and patient-focused drug development.
 
The public docket on patient-focused drug development for chronic pain—opened when the meeting was announced in May—has already received 973 comments. FDA’s Dr. Sepideh Haghpanah said at the meeting the agency will issue a summary of the received comments.
 
Panel discussions underscored the consequences of the conversation around the US opioid epidemic being largely centered on minimizing prescriptions, despite previously existing barriers to access for legitimate patients.
 
Patients called on FDA to tell the public “the truth” about prescription opioids, arguing that these are by and large safe and effective for both short and long-term use.
 
One of the barriers in obtaining pain medication relates to prescribing guidelines developed by the US Centers for Disease Control and Prevention (CDC). “Nobody will take over another doctor's prescription” because of the paperwork that FDA and the CDC requires, a patient said.
 
Other patients highlighted an additional remaining barrier to FDA-approved chronic pain medication—the associated side effects. For example, a patient battling rheumatoid arthritis and osteoarthritis chose opioids over NSAIDs. This is because opioids have helped helped improve quality of life while an NSAID like naproxen can cause a number of side effects like tachycardia and high-blood pressure, patients said.
 
These real-life stories highlighted the need to strike the “right balance” between preventing opioid misuse/abuse and safeguarding access for “legitimate patients” in the fight against “the many facets of this complex public health crisis,” FDA Commissioner Scott Gottlieb said in a statement issued Monday.
 
FDA’s 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 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.” He added that patient input is key in pursuing these goals.
 
Last month, the agency issued draft guidance on patient-focused drug development, further encouraging the incorporation of patient input in drug development programs.

Categories: Regulatory News

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