Profiting from the opioid crisis

By Bob Barr – – Tuesday, March 6, 2018

ANALYSIS/OPINION:

Whether one labels it a “crisis” or an “epidemic,” or understates it simply as a “problem,” no reasonable observer can consider the human and monetary cost of opioid abuse anything other than a matter of the utmost national importance.

In 2016 alone, more than 64,000 people died from drug overdoses in America; the highest number ever recorded. The opioid crisis has cost the United States more than $1 trillion since 2001. President Trump appropriately has declared it a “public health emergency.” To try and end the epidemic and obtain for addicts the help they need, the demand for opiate-treatment drugs has skyrocketed; unfortunately, a result not without its own set of problems.

It is well-known that the drug buprenorphine, properly administered, can manage opioid dependency. The drug reduces craving for opioids, and in a properly managed regimen, truly can reverse the tide of addiction and death.

However, one drug company — Indivior, which produces buprenorphine under the patent Suboxone — has viewed the opioid crisis as nothing more than a profit-making opportunity. Rather than increasing the quantity of opiate treatment drugs available, Indivior has done everything possible to keep its own prices high and lock competitors out of the market. This profit-driven effort has been called a “shocking scheme to profit off of heroin addicts,” with the drug maker’s actions leading to “nearly a billion dollars in undeserved profits.”

This scheme appears not only to violate state and federal antitrust laws, but every notion of common decency and ethics in coming together to solve our country’s current drug epidemic.

Indivior’s actions, like the opioid crisis itself, began years ago, but at least now are beginning to garner the public’s attention. When Suboxone entered the market in tablet form in 2002, it was granted patent exclusivity for seven years; meaning no generic copies could enter the market during that time. As this exclusivity neared its expiration, the company engaged in a “product-hopping” scheme, in which it made slight, medically-unnecessary alterations to its product in order to preserve patent protections and box out competitors; in short, to maintain its product monopoly.

Although its tablet seemed to work fine, the company touted “unfounded pediatric safety concerns” and began to develop a dissolvable film version, like a breath strip. These small changes allowed Indivior to expand the length of its patent and repel generic competitors who could, and were ready to, enter the market and charge lower prices. Indivior’s claims also appear hypocritical — although the tablet form of the drug was removed from the U.S. market, the company continued to sell the drug in tablet form overseas with no problem, and even increased its marketing.

This sort of naked, profit-minded behavior in a true health emergency is unconscionable. This is why, in September 2016, a bipartisan group of 36 state attorneys general announced that they were suing Indivior for illegally driving up the cost of a key treatment for opioid addiction. The company is charged with manipulating Suboxone to extend its patent and discourage lower-priced competitors to enter the market for buprenorphine.

However, while the lawsuit by the attorneys general has been pending for nearly a year and a half, no tangible results or relief has been seen. The opioid crisis has only worsened; to the degree that overall life expectancy in the U.S. dropped last year, driven by the increasing number of drug deaths. Now, drug overdoses — not heart disease — are the leading killer of Americans under the age of 55.

While the federal government has a legitimate role to play, the real leadership must come from the state attorneys general; primarily by being far more aggressive in pressing legal action. Simply filing a lawsuit and issuing a news release does little but raise expectations; real commitment must come through seeking injunctive relief and emergency hearings to get the ball rolling.

The Congress, however, has an important role to play; especially given the lack of movement in the courts. On Feb. 28, that effort came into focus with a hearing on the opioid crisis by a subcommittee of the House Energy and Commerce Committee. Hopefully, this congressional effort will not only continue, but accelerate.

Among the options on the table should be ending predatory pricing and monopolistic behavior by the very companies that claim to be cohorts in the battle to end opioid addiction. Congress — and the Department of Justice — must prioritize and deal with anti-competitive practices by drug manufacturers that place profits above competition, sound pharmaceutical ethics and patient outcomes.

If this effort to save a generation of our fellow citizens requires criminal prosecutions in addition to legislative and civil remedies, then so be it. The alternative is far too dread to allow.

• Bob Barr, a lawyer in Atlanta, Georgia, was a federal prosecutor and a Republican U.S. representative from Georgia.