Today, Rep. Bill Keating (D-MA) announced federal legislation addressing abuse-deterrent formulations for commonly abused painkillers. The Stop the Tampering of Prescription Pills (STOPP) Act was written by Rep. Keating, who then reached across the aisle for bipartisan support to Rep. Rogers (R-KY), Chairman of the House Appropriations Committee. Other Massachusetts Members who are cosponsors of Rep. Keating's legislation include Reps. Tierney, Lynch, Markey and Kennedy.
Rep. Keating originally introduced the STOPP Act, first-of-its kind legislation to address prescription drug abuse, in July of 2012. He is a member of the Congressional Caucus on Prescription Drug Abuse.
"As a former District Attorney, I have investigated far too many deaths related to prescription drug abuse," said Rep. Bill Keating. "In my state of Massachusetts, almost two people a day die from overdoses. This is a silent epidemic and it is destroying families, not just in Massachusetts, but across the country. According to CDC data, more people are dying from overdoses -- the majority of which are cause by prescription drugs -- than automobile accidents. With the FDA's recent approval of the first opoid-based generic drug to re-enter the American market without abuse-deterrent technology, we need the STOPP Act now to stem this dangerous tide. The STOPP Act isn't a silver bullet but it will save lives. What this legislation is proposing, the FDA should be doing on its own. Because they are not, we are ready to act. I thank my colleagues Reps. Rogers, Rahall and Kennedy for standing behind this critical legislation."
"Today this country sees more deaths from prescription drug overdoses than from heroin and cocaine combined," said Rep. Joe Kennedy (D-MA). "In the face of abuse that grows more prevalent and painful by the day, measures like the STOPP Act are critical. I applaud Congressman Keating and Congressman Roger's consistent leadership on this issue and look forward to working with them to help the overwhelming number of families and communities across the country battling this epidemic."
STOPP Act Specifics
According to recent data from the Centers for Disease Control and Prevention, deaths related to drug abuse exceeded those related to motor vehicle accidents for the second year in a row. That data further suggests the number of deaths from drug abuse is on the rise. Prescription drugs are the country's fastest growing area of drug abuse, second only to marijuana but ahead of cocaine, heroin, methamphetamine and other drugs.
There are three categories of prescription drugs that are most abused: stimulants, depressants and pain medication. Of the three, abuse of opiate-based pain drugs -- comprising some of the most powerful medications available -- has increased dramatically. While the benefits of these products in treating and managing pain are widely recognized, the growing misuse and abuse of these products has resulted in a sharp increase in fatal overdoses and heroin addiction. In fact, more people die of prescription opioids than cocaine and heroin combined.
The time-released characteristics of powerful opioids are compromised when crushed or dissolved resulting in the full potency of the drug being released all at once, and studies have shown that drug abusers tend to crush or otherwise break down time-released products into a form that can be snorted or injected for a more intense high.
In 2010, the manufacturer of time-released OxyContin introduced abuse-deterrent features that make it more difficult for the drug to be misused. Yet, FDA recently approved the generic of an opoid-based drug that employs abuse deterrent technologies despite the fact that the generic failed to include similar preventative technology. And there are more of these drugs currently waiting for approval. The availability of these new generics that are not abuse deterrent will compromise the benefits of the preventative technologies currently being employed.
The STOPP Act is the first federal legislation that directs pharmaceutical manufacturers to invest in research and production to formulate tamper resistant drugs in order to compete with drugs of a similar nature that already employ tamper resistant technologies.
If a pharmaceutical manufacturer submits an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) that refers to a listed drug that utilizes a tamper resistant formulation, the application must include data demonstrating that the new drug is tamper resistant to a degree comparable to the listed drug. If the ANDA does not make such a showing, FDA must refuse approval of the application.
FDA must refuse approval of a New Drug Application (NDA) for a new drug, which is an oral dosage form, that contains a controlled substance as an active ingredient and does not utilize a tamper resistant or abuse deterrent formulation, where FDA has previously approved a drug that: (1) is an oral dosage form, (2) contains the same controlled substance as an active ingredient, (3) utilizes a tamper resistant or abuse deterrent formulation, and (4) has not been discontinued from marketing.
Any NDA subject to refusal under this provision must submit data demonstrating that the new drug utilizes a tamper resistant formulation or abuse deterrent formulation, as applicable.
If a listed drug begins to utilize a tamper resistant formulation, any drug previously approved under an ANDA that refers to such listed drug must be deemed not therapeutically equivalent -- and thus not substitutable -- to the listed drug, unless and until the generic also begins to utilize a tamper resistant formulation, under a time frame that is mutually agreed to by the drug company and FDA.
If approval of a listed drug has been withdrawn, or if such drug is withdrawn from sale, after a tamper resistant version of that drug has been approved under another NDA, then such drug shall be considered withdrawn from sale for a safety reason.
FDA must refuse a suitability petition where the petition references a listed drug that utilizes an abuse deterrent formulation, and the new drug contains any active ingredient(s) that differ in any respect from those contained in the listed drug. As a result, any such new drug must be approved under an NDA rather than an ANDA.
The STOPP Act will have no impact on patients that rely on the pain management features of these drugs when dealing with chronic pain and end-of-life pain issues. The practical effect of legislation will be to make the abuse of opioids and other controlled substances more difficult, while at the same time insuring that those who need pain relief receive it.
The bill also grants the FDA waiver authority for drugs that are absolutely critical and experiencing drug shortages for the period in which those drugs are in high demand and there is no tamper resistant alternative.