Tag Archives: Regulations

Drug reform needed to address Wisconsin’s opioid crisis

A public health crisis is unfolding in America due to a growth in opioid addiction. Over 21 million Americans above the age of 12 are struggling with substance abuse, and drug overdoses have become a leading cause of accidental death as a result. Unfortunately, drug policy change has altered at a slow pace, and Wisconsin continues to rely on outdated medicines and policies.

Over the last 14 years, doctors in Wisconsin have relied on the prescription medicine Suboxone to assist addicts with reducing withdrawal symptoms. Unfortunately, our state’s current regulatory framework is preventing doctors from choosing the best treatment for their patients, as Suboxone employs a de facto monopoly. In the interest of public health and improving the lives of average Wisconsinites, it’s time for our public health policy to allow for more access to innovative addiction treatments.

Suboxone was classified by the Food and Drug Administration (FDA) as orphan drug, a privilege reserved for treatments of rare diseases. One of the perks of this classification has been seven years of exclusive rights to sell the drug, in which Suboxone’s manufacturer has profited to the sum of billions.

Despite Suboxone’s patent expiring in 2012, the company still benefits from its monopoly-like status. In 2012, over 9 million prescriptions were written and the company earned over $1.2 billion in net revenues. The company also tried effortlessly to fight against generic competition, claiming tablet forms would be dangerous to kids, giving the company a market stranglehold due to their patent-protected filmstrip. The FDA disagreed and approved generic tablets and called for an investigation by the Federal Trade Commission to address the anticompetitive business practices of Suboxone’s manufacturer.

Continue reading at Wispolitics.com.

FDA’s New E-Cig Regs Will Kill

The Food and Drug Administration released its long awaited e-cigarette regulations on Thursday. E-cigarette users’ worst fears are confirmed—these regulations will destroy the burgeoning industry, leading to increased mortality and higher healthcare costs.

Though the FDA marketed its regulations as restrictions on minors who purchase tobacco products, the 499-page release contains far more. Perhaps the most ridiculous FDA claim is that these regulations will lead to increased innovation—even though the agency admits that 99 percent of the market will not be able to comply.

As stated on page 267 of the regulations, “FDA believes that [premarket review] (and the deeming rule as a whole) will not stifle innovation but could, instead, encourage it.” This is a nonsensical claim that could only be made by a government agency.

Through these regulations, the FDA “deems” that all tobacco products are under its regulatory scope. Hookahs, cigars, pipe tobacco, and electronic nicotine delivery systems (ENDS) were not previously covered under the FDA’s authority to regulate tobacco, which began with the 2009 Family Smoking Prevention and Tobacco Control Act. Now, all tobacco products that were not commercially marketed on February 15, 2007 (the predicate date) are required to gain FDA approval. Tobacco products that were available on the predicate date are exempt from the FDA approval process.

Newer tobacco products will be able to stay on the market if they show that they are “substantially equivalent” to a product that was commercially available on predicated date. Virtually no ENDS were available to American consumers at that time, meaning each currently available vaping product will have to go through the FDA’s other path to market, the premarket tobacco product application process.

Read the full article at Economics21.