FDA gains authority after SUPPORT Act, but is authority enough?

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/bernie_photos)
(Image: Getty/bernie_photos)

Related tags: Opioid epidemic, Opioid, Regulation, Fda, FDA approval, fda commissioner, Prescription drug, overdose, legislation

President Donald Trump signed the SUPPORT act granting the FDA additional authority to combat the opioid epidemic, but a pain management CRO argues that opioid addiction isn’t the only crisis.

Substance Use-disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT​) for Patients and Communities, was signed by President Trump on October 24, 2018.

The Support Act works in four broad ‘buckets’ according to US Food and Drug Administration (FDA) Commissioner Scott Gottlieb: To expand recovery and treatment options, authorize improved coordination between US Customs and US Border Protection, while funding the advancement of non-opioid pain management therapies and decreasing exposure to opioids.

While the commissioner did not give comment on how the FDA will expand the recovery and treatment options available to those struggling with opioid use disorder, the Act itself granted the FDA power to work on developing options​. 

However, the bill also has it’s shortcomings, according to Lynn Webster, VP of Scientific Affairs and Neuroscience at PRA Health Sciences, a clinical contract research organization (CRO).

Webster stated that from his perspective, increased funding provided for research to develop effective and non-addictive analgesics is one of the most important elements of the legislation.

The Act grants the FDA rights to fund and pursue more research needed to understand the long-term implications of opioid use, as well as non-opioid innovative treatments for pain.

“With increased funding for treatment, the industry will follow the money. That is not a bad thing, but it isn’t addressing the root causes of the opioid crisis,”​ Webster said.

However, he also noted that the legislation doesn't mandate payers to provide coverage for substance use disorder without the need for preauthorization.

“Regardless of the amount of increased funding, access to care is not guaranteed. Delay in treatment due to the need for preauthorization or step therapy often ends in tragedy,”​ he explained.

“We have a healthcare system that does not adequately treat people in pain or provide sufficient access to addiction treatment. Increased funding for treatment doesn’t mean it will be available to all the people who need it, when they need it."

Webster stated that the root cause​ of the drug crisis is complex – one not addressed by the legislation.

“There are two public health crises, pain and addiction. The pain crisis has all but been ignored due to the opioid crisis,” ​he added. “There are tens of millions of Americans who live in unimaginable pain and are not receiving the care they deserve.”

According to Webster, the legislation omitted aspects that could have had an impact on reducing opioids while also helping people in pain​.

US Customs and Border Protection

The FDA is now able to more efficiently stop illegal, illicit, unapproved, counterfeit and potentially dangerous drugs from entering the US through the international mail facilities (IMFs), Gottlieb explained.

“We need to understand that prescription opioids are only small part of the drug crisis. Most of the drug problem is due to drugs smuggled into the US from China and Mexico,”​ Webster added.

Per the legislation, the agency also will be able to deploy its Office of Criminal Investigations​ (OCI) to IMFs to work more with US Customs and Border protection and FDA staff. These investigations have proven to be successful in creating accountability in criminal activity.

Gottlieb said that in FY17 the investigations resulted in 115 arrests or prosecutions, more than 60 guilty pleas, and more than 80 convictions; and in FY18 more than 120 arrests and prosecutions, 80 guilty pleas, and 90 convictions.

With US support, OCI’s international network can be expanded to target illicit movement and focus on additional criminal enforcement resources.

The FDA will now be able to bring actions to debar those who have been convicted of a felony involving illegal importation of drugs or have engaged in importing misbranded drugs for commercial sale. Once debarred, the FDA can prohibit future drug importation by that entity, and law enforcement can take action against debarred entities.

Reducing exposure

The legislation also will allow the FDA to advance efforts to reduce exposure to opioids as a way of preventing new addiction. To do so, the FDA can now take additional steps to ensure that prescribed opioids are clearly indicated for correct patient use.  

Additionally, the FDA can now require packaging​ controls the dispensing of opioids. Unit dose blister packs for opioids and other drugs that pose a risk of abuse could now be required, Gottlieb explained.

This form of packaging, according to the commissioner, could become the default option for most post- procedure uses and could discourage physicians from prescribing opioids for long use in situations where short durations are clinically appropriate.

However, Webster counter-explained, that there has been a continual decline in opioid prescriptions over the past several years, while drug overdoses continue to surge.

See More:​ Infographic: FDA gains authority to prescribe less, opioid prescriptions have decreased 

According to CDC data​, in 2012 there were 255.2m prescriptions for opioids in the US with a prescribing rate per 100 persons of 81.3%. Whereas, in 2017 there were 191.2 million prescriptions for opioids in the US with a prescribing rate pre 100 persons of 58.7%.

Gottlieb said that the newly proposed approach could reduce the overall number of drugs in circulation and may have the potential to lower the rate of new opioid addiction by addressing excess supply that could be inappropriately accessed.

Webster disagreed: “There is a disconnect between the amount of prescribed opioids and the number of drug overdoses.”

The new law also supports the FDA’s current actions to promote the development of evidence-based opioid prescribing guidelines for treating acute pain. As part of this, the agency recently awarded a contract to the National Academies of Sciences, Engineering, and Medicine (NASEM) to help advance the development of the guidelines​.

Related topics: Markets & Regulations, Regulatory affairs

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