Keating applauds Federal Drug Administration's decision on Oxycontin

He introduced this first-of-its kind legislation to address prescription drug abuse
Rep. Keating originally introduced The Stop the Tampering of Prescription Pills (STOPP) Act, first-of-its kind legislation to address prescription drug abuse, in July of 2012.

Keating: FDA made right decision on Oxycontin

Below is Rep. Bill Keating’s statement with regard to the US Food and Drug Administration’s decision to prevent generics of the original, crushable OxyContin from hitting the market without employing abuse-deterrent technology. First generation OxyContin’s patent was set to expire today.

“During this time of great sadness in my home state of Massachusetts, I have received some news that will thankfully have a positive effect on the Commonwealth and across the country. It is not every day that you can say one decision will save lives, but I truly believe this will. This afternoon, the FDA decided to prevent generic forms of OxyContin that do not employ abuse deterrent formulations from hitting the market and further increasing the potential for abuse and addiction. I commend the FDA and Commissioner Hamburg for their responsible, thoughtful decision. It is a welcome first step in an ongoing process.

"Since I first introduced the STOPP Act last Congress – and reintroduced it last month – I have been fighting to require these dangerous, prescription painkillers to employ abuse-deterrent technologies. That is a key component of the STOPP Act and with today’s decision, I am happy to see that the FDA has chosen to implement part of my legislation.”

Rep. Keating originally introduced The Stop the Tampering of Prescription Pills (STOPP) Act, first-of-its kind legislation to address prescription drug abuse, in July of 2012, and he reintroduced this Congress in March. He is a member of the Congressional Caucus on Prescription Drug Abuse.

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.

Three categories of prescription drugs that are most abused:

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[i].

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.

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