Statement of the Honorable John Conyers, Jr. for the Hearing on “Treating the Opioid Epidemic: The State of Competition in the Markets for Addiction Medicine” Before the Subcommittee on Regulatory Reform, Commercial and Antitrust Law
Sudden and sharp increases in the cost of life-saving prescription medications have caused much public outcry, most recently regarding the substantial spike in the price of EpiPen, which is used to treat life-threatening allergic reactions.
Although today’s hearing focuses on competition in the markets for a particular set of life-saving drugs -- namely, those that treat opioid addiction -- I hope that there are some broader lessons that we can draw from our discussion today.
To that end, I would like our witnesses to address the follow issues. To begin with, the witnesses should discuss the real-life consequences of the opioid addiction epidemic and the impact of rising prices for medications that treat opioid addiction.
According to the Centers for Disease Control and Prevention, there were more than 28,000 deaths in 2014 resulting from opioid overdoses. In fact, 6 out of 10 drug overdose deaths that year resulted from opioid overdoses.
Medications like Naloxone revive an opioid overdose victim in the critical moments after he or she has stopped breathing as a result of an overdose.
Yet the price of this drug, in both its generic and branded forms, has skyrocketed in recent years, according to public health and police officials.
Prices for the drug have increased by 50% or more, according to some reports. As a result, the ability of emergency responders and individuals to purchase this critical life-saving medication is being jeopardizes.
Other generic and branded medicines that are designed to gradually wean addicts from their opioid use have also seen similar price increases.
As the statistics demonstrate, addressing the consequences of these price increases is no mere academic matter. It is beyond dispute that such price increases have had a devastating impact on patients, their families, insurers, first responders, and health care providers.
In addition, I would like the witnesses to consider whether current law strikes a proper balance between incentivizing investment in new pharmaceutical products and ensuring vigorous competition.
Under both our patent and regulatory systems, manufacturers of brand-name drugs are entitled to temporary exclusivity periods for their products during which other firms are prevented from offering competing products.
These exclusivity periods are designed to provide an economic incentive for manufacturers to invest in developing new products, but the result is that prices for brand-name drugs remain high.
After the exclusivity periods end, competition in the form of the introduction of generic versions of the brand-name drug, is supposed to lead to decreases in drug prices.
Indeed, the availability of generics is the primary means of ensuring competition and lower prices in pharmaceutical markets.
Nevertheless, there is a concern that some brand-name manufacturers have manipulated the current patent and regulatory regimes to extend what are supposed to be their time-limited monopolies.
We should explore whether there should be a better balance.
Finally, the witnesses should address the factors responsible for the skyrocketing cost of generic opioid addiction drugs and the actions that Congress should take in response.
Prices for almost all opioid addiction medicines have risen, not just those for brand-name products.
This situation undermines the competition-based rationale for encouraging generics to enter the market in the first place.
We in Congress need to focus on constructive ways to respond to this problem.
So, I accordingly look forward to hearing any thoughtful suggestions from our witnesses today and I thank them for their participation.