After Deliberation, FDA Recommends Limits on All Prescription Painkillers

In January of this year, the FDA convened an advisory committee to hear evidence related to hydrocodone and related prescription painkillers, which voted in favor of reclassifying those prescription painkillers as Schedule II. The DEA has also pushed for this change for years.

Now, the FDA has agreed to back the recommendation.

Hydrocodone is an opioid painkiller, much like oxycodone and related prescription painkillers. However, hydrocodone, which is the active ingredient in popular prescription painkillers like Vicodin, has previously been classified as Schedule III, which allows doctors to prescribe the medication without numerous followup visits to re-prescribe. This allows patients with serious chronic pain problems to have better access to a painkiller that will work.

“Rescheduling the products to Schedule II would create significant hardships for all — leading to delayed access for vulnerable patients with legitimate chronic pain,” said the National Community Pharmacists Association, in a statement.

The DEA, however, noted that 75% of prescription painkiller abuse and addiction stems from ease of access to hydrocodone-based drugs.

However, prescription painkiller addiction is a growing problem in the US, to the point that some reports have labeled it an epidemic. These highly addictive opioid substances are chemically similar to heroin and methadone, and in Schedule II drugs like Oxycontin, are tightly regulated to watch for patterns of addiction or abuse.

“Opioids are important pain relieving medications that provide significant benefits when used appropriately,” Douglas Throckmorton, MD, deputy director of the FDA’s Center for Drug Evaluation and Research (CDER), said during a press briefing, according to USA Today. “But they have significant risks associated with inappropriate patient selection and improper use, whether accidental or intentional.”

After many months of debate, the FDA has decided to take their advisory panel’s recommendation and announced on their website on Thursday, October 24th, that hydrocodone-based prescription painkillers should be subject to the same restrictions as other narcotic prescription painkillers, like oxycodone and morphine.

The FDA’s top drug regulator, Dr. Janet Woodcock, said in a statement Thursday: “The FDA has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States.”

“Today was a tremendous step forward in fighting the prescription drug abuse epidemic that has ravaged West Virginia and our country,” said Democratic Sen. Joe Manchin, in a statement. “Rescheduling hydrocodone from a Schedule III to a Schedule II drug will help prevent these highly addictive drugs from getting into the wrong hands and devastating families and communities.”

In contrast, Kevin Schweers, a spokesman for the National Community Pharmacists Association, said, “The FDA’s reported decision will likely pose significant hardships for many patients and delay relief for vulnerable patients with legitimate chronic pain, especially those in nursing home and long-term care.”

The Strom Law Firm Can Help with Charges of Prescription Drug Abuse

If you have received criminal drug abuse charges, or are suspected of abusing prescription painkillers, you are not automatically guilty, and you do not give up any of your rights. The attorneys at the Strom Law Firm can help defend you. We offer free, confidential consultations to discuss the facts of your case. Do not let criminal drug charges such as trafficking or possession ruin your reputation and career prospects. Contact us today. 803.252.4800.