Opioids are widely prescribed and carry a risk of abuse, misuse and death. In 2009, there were nearly 425,000 emergency department visits involving non-medical use of opioid analgesics. According to estimates from the Centers for Disease Control and Prevention, 14,800 Americans died from overdoses involving opioid pain relievers in 2008. In 2009, there were 15,597 deaths involving an opioid medication.
To address these issues, four members of the U.S. House of Representatives recently introduced legislation requiring most pain drugs to adopt abuse-deterring safeguards, the broadest congressional attempt at curbing the nation's prescription-drug problem. According to the Wall Street Journal, the bipartisan bill seeks to eventually make most of the nation’s 137 million annual painkiller prescriptions feature some form of abuse deterrence, such as pills that are harder for abusers to crush open or inject. The bill provides a framework for the Food and Drug Administration (FDA) to follow in dealing with drug companies, but it leaves vague the exact details of how drug makers could meet new standards.
The Centers for Disease Control (CDC) reports that improper “use of prescription painkillers costs health insurers up to $72.5 billion annually in direct health care costs and opioid pain medications now kill more people than heroin and cocaine combined, and accounted for almost 74% of fatal prescription drug overdoses in 2008.
As a first effort to address these issues, President Obama launched the national prescription drug abuse plan in 2011 to combat prescription drug misuse and abuse. More recently, FDA released its final Risk Evaluation and Mitigation Strategies (REMS) for extend-release (ER) and long-acting (LA) opioid medications. This is the first time that the FDA has mandated a class wide REMS and much of what is recommended will be looked at closely for future class REMS.
After input from many stakeholders dating back to November 2011, FDA also released the “Blueprint for Prescriber Continuing Education Program” regarding the use of opioids. The Blueprint contains core messages intended for use by continuing education (CE) providers to develop educational materials to train prescribers of long-acting and extended release opioids under the required opioid REMS.
In addition to these recent efforts, recent investigations and reports into opioid manufacturers caused Senators Max Baucus (D-MT) and Charles Grassley (R-IA), to send letters to three pharmaceutical companies, Purdue Pharma, Endo Pharmaceuticals and Johnson & Johnson, as well as five groups that support pain patients, physicians or research: the American Pain Foundation (APF), American Academy of Pain Medicine, American Pain Society, Wisconsin Pain & Policy Studies Group, and the Center for Practical Bioethics.
The Federation of State Medical Boards (FSMB), the trade group for agencies that license doctors, also received a letter, as did The Joint Commission, an independent nonprofit that accredits hospitals nationwide and made pain management a national priority in 2001. The letters inquired into the nature of funding from these companies and educational materials that the patient support groups produced and gave to patients and doctors.
Under the legislation (H.R. 6160), also known as the “Stop Tampering of Prescription Pills Act (STOPP), pain medications that don’t adopt certain safety features would be removed from the FDA's approved list of generic drugs. In other words, if a manufacturer submits a new drug application (NDA) or abbreviated new drug application (ANDA; for generic drugs), the manufacturer must include data demonstrating that the new drug is tamper resistant to a degree comparable to the listed drug. Otherwise, FDA would be forced to deny approval of the application.
As noted by the FDA Law Blog, the legislation also provides that:
- 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;
- 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.
Such laws could help slow the nation’s growing addiction to prescription painkillers, which killed more people in 2011 than heroin and cocaine combined.
Only a handful of branded painkillers, such as Purdue Pharma LP's OxyContin or Endo Pharmaceuticals Inc.’s Opana, have in recent years been made with so-called tamper-resistant formulations. Most of the generic painkillers, however, don't have such safeguards.
“This bill should help protect first-time users and younger people who gain access through relatives or their own family's medicine cabinets,” said Rep. Bill Keating (D-MA), lead sponsor of the bill, in an interview. The bill is also co-sponsored by Representatives Mary Bono Mack (R-CA); Stephen F. Lynch (D-MA); Nick J. Rahall II (D-WV); John Tierney (D-MA); and Edolphus Towns (D-NY). The bill was referred to the House Committee on Energy and Commerce. The article also noted that Rep. Hal Rogers (R-KY) is a co-sponsor.
Congress is “understanding the scope of this and looking at it as a major public health epidemic,” Mr. Keating said.
Abuse-deterrent safeguards are a timely issue. Next year, patents for OxyContin and Opana are set to expire. The FDA, which hasn’t ruled whether the abuse-deterrent features should be required on the generic versions, has said it would provide guidance by the end of this year.
The article noted that the proposed bill “stops short of setting time lines for how quickly painkillers without abuse deterrents would have to comply. The legislation stipulates that the FDA and individual companies work out the timing.”
“The proposed legislation would be detrimental to patients and could potentially remove FDA-approved safe and effective generic medicines from those who rely on them," said Ralph G. Neas, president of the Generic Pharmaceutical Association, an industry trade group. “Addressing prescription-drug abuse is of utmost importance to the generic pharmaceutical industry. Policy makers should let the medical evidence guide actions in addressing this critical issue,” he added.
Recent legislation covering prescription-drug abuse has stalled in Congress. Last month, the Senate unanimously approved tighter restrictions around the prescribing and dispensing of hydrocodone. But the amendment, part of the reauthorization of the FDA’s user fees, was ultimately removed in the House version of the bill. Opposition was loudest from pharmacist, supermarket and drugstore groups—not big pharmaceutical lobbyists, said Sen. Joe Manchin III (D., W.Va.), who proposed the amendment.
“There are a lot of tentacles out there,” said Mr. Manchin, in an interview.
The reformulations of Opana and OxyContin have led to a drop in sales and abuse in Ohio, suggesting the safeguards are deterring addicts, said Orman Hall, director of the state’s department of Alcohol and Drug Addiction Services. He supports safeguards on painkillers. “We are already awash in a sea of generic opioids, and adding another generic to the mix will not be helpful,” Mr. Hall said.
Abuse-deterrent formulations are a neutral issue for legitimate pain patients, experts said. “As long as the quality of the medication is the same, people aren’t going to care” if there is a tamper-resistant formulation, said April Rovero, president of the National Coalition Against Prescription Drug Abuse, a nonprofit that tries to build broader community awareness of painkiller misuse.
A Purdue Pharma spokesman said the company did not increase the price of OxyContin when it released its reformulated product in August 2010. The reformulated Opana also was sold at the same price as the original version after it launched earlier this year, an Endo spokesman said.