Panel: The FDA Desperately Needs to Review its Approach to Opioids

In a report, the National Academy of Sciences, Engineering, and Medicine (NASEM) is calling on the U.S. Food and Drug Administration (FDA) to review the safety and effectiveness of opioid painkillers. The panel of experts says monumental changes are needed to the way in which physicians treat pain, their patients cope with pain, and government and private insurers support individuals’ treatment for chronic pain. [1]

However, the panel says in no uncertain terms that efforts to prevent future opioid addicts will unfortunately drive some current painkiller abusers to seek harder street drugs, including heroin and fentanyl.

The panel wrote that:

“It is therefore ethically imperative to couple a strategy for reducing lawful access to opioids with an investment in treatment for the millions of individuals [already addicted to opioids].

The FDA commissioned the panel in 2016 to shape advice for how the agency should tackle the nation’s opioid epidemic. Many experts, including those on the panel, say the answer to the problem lies in regulating drug companies, as well as prescribers.

As we speak, lawmakers in Washington are debating a healthcare bill that would reduce access to addiction treatment – the polar opposite of what the panel calls for in its comprehensive report. What is needed, panel members say, is for states and the federal government to provide “universal treatment to addiction in hospitals, community-based programs, jails, and prisons.

The topic is a bone of contention for many people who don’t believe taxpayers should have to foot the bill for such treatment. But according to the panel, it is the only way to bring an eventual end to the opioid crisis sweeping America. Make no mistake about it – it is going to take years to gain control over the situation.

Source: U.S. Centers for Disease Control

A member of the report committee, Dr. Aaron Kesselheim of Harvard Medical School said:

“Our recommendation is for a much more systematic approach, integrating public health decision-making into all aspects of opioid review and approval. It would be an ambitious undertaking.” [2]

While the panel stopped short of acknowledging that the war on drugs has not worked, it urged states to reject the current trend of cracking down hard on illicit drug use. This, it said, will reduce harm to opioid users who have turned to the streets to supply their habit.

Instead, the panel said that states should adopt needle exchanges, safe havens for those who inject drugs, and wider access to naloxone – a drug that reverses overdoses from opioids, including heroin. [1]

In deciding how to regulate opioids, the FDA should study how the drug will affect patients’ families, society at-large, and the black market for drugs, the panel continued.

Kesselheim said:

“This is in distinction to the traditional approach that the FDA takes when it evaluates products. But the particular characteristics of opioids, we believe, requires a certain amount of what we term ‘opioid exceptionalism’ from the regulator.

… Overzealous promotional and financial relationships between the pharmaceutical manufacturers of opioids and physicians through the ’80s, ’90s, and 2000s, I think, at this point, has been shown to be a contributor to overprescribing in this area.” [3]

Other recommendations by the panel include:

  • Requiring drug companies to follow stricter rules for marketing opioids than they would for other drugs.
  • Developing campaigns to inform doctors and patients about other was of managing chronic pain. These campaigns should not be run by drug companies, however, even though many drug companies sponsor ongoing pain-management education programs for physicians.
Source: U.S. Centers for Disease Control

In 2016, the CDC released fresh guidelines intended to limit the prescribing of opioids, though there is no legal mandate for physicians to follow them. The agency recommended, among other things, that:

  • Doctors don’t immediately prescribe opioids to treat pain. Instead, physicians should prescribe non-drug interventions first, such as exercise therapy and weight loss.
  • When a doctor does prescribe an opioid, he or she should start the patient on the lowest dose possible, and prescribe immediate-release opioids for short periods of time, rather than for weeks or months at a time.
  • Doctors should urine-test patients to make sure they are following the prescription’s directions.

Read: The DEA Will Slash Opioid Production 25% by 2017

Also in 2016, the FDA published draft guidelines outlining testing standards for harder-to-abuse generic opioids. Under those guidelines, the FDA can only approve a generic painkiller if the maker can prove it is the bioequivalent of a brand-name medication. Prior to that, generic drugs were not individually scrutinized for safety and efficacy the way that brand-name drugs were.

Additionally, the FDA required black-box warnings – the FDA’s most serious drug warning – on all fast-acting opioids concerning the risks for addiction, misuse, overdose, and death.


[1] Los Angeles Times

[2] The Street

[3] Pacific Standard

U.S. Centers for Disease Control

U.S. Centers for Disease Control

Storable Food

California Senate Passes Bill Banning Drug Company Gifts to Doctors

On May 18, the California Senate passed a bill that would ban pharmaceutical companies from giving gifts to doctors. The Senate voted 23-13 in favor of sending the bill to the Assembly. [1]

For the bill, SB 790, California lawmakers used a similar 2009 Vermont law enacted in 2009 as a template.

If the bill is signed into law, doctors would no longer be able to receive perks, such as airline tickets and lavish meals, from drug companies. According to Sen. Mike McGuire, the bill would lower healthcare costs, in part because doctors who receive gifts are more likely to prescribe costly drugs. [2]

Drug companies unload more than $1.4 billion a year on California doctors in the hopes they will promote and prescribe their products, said McGuire, a Democrat who represents a district west of Sacramento.

McGuire said that in 2014, doctors in his state received more gifts and payments from pharmaceutical companies than in doctors any other state. [3]

Read: Need a Link Between Federal Reps and Drug Companies? Here it is

“While we have witnessed the cost of drugs rise over the past decade, industry profits have also grown significantly. We should be all standing for seniors and taxpayers to drive down the cost of prescription drugs.” [1]

According to a recent study by researchers at UC San Francisco, doctors who receive gifts from drug companies are 2 to 3 times more likely to prescribe name-brand drugs over cheaper, generic drugs. [2]

An even more recent study found that doctors at teaching hospitals are more likely to prescribe generic drugs when pharma reps are kept at bay.

Source: Pro Publica

Others have a different take on SB 790. State Sen. Ted Gaines argued that drug company gifts “provide the funding for research, for cures.”

He added:

“Why would we do anything to diminish the ability of pharma companies to be successful in providing these new products?” [3]

Senate minority leader Patricia Bates said the bill would discourage physicians from participating in clinical trials or restrict California’s access to experimental drugs.

However, the bill would still permit doctors to receive salaries for participating in clinical trials, and would allow for the payment of meals up to $250 per year for individual doctors.

The bill is headed to the state Assembly, the California lower Legislature, for consideration.


[1] Associated Press

[2] Daily Health Post

[3] RT

Pro Publica

Storable Food