FDA to recommend rescheduling of opioid painkiller hydrocodone from CIII to CII
SILVER SPRING, Md. — The Food and Drug Administration plans to recommend stronger regulations for a commonly used opioid painkiller.
In a statement Thursday, FDA Center for Drug Evaluation and Research director Janet Woodcock said the agency would formally recommend to the Department of Health and Human Services that products containing 15 mg or less of the drug hydrocodone’s be reclassified as Schedule II controlled substances, from the current Schedule III. The higher scheduling would impose tougher regulations on hydrocodone, which is an active ingredient in products like AbbVie’s Vicodin, among other products. The Drug Enforcement Administration, which regulates controlled substances, proposed the change in 2009, and the FDA will submit its recommendation in December.
The change is being recommended in light of Vicodin being a common target for abuse and misuse, which itself feeds the problem of pharmacy robberies and can have potentially fatal consequences for people taking the drug improperly or recreationally.
Abuse and misuse of opioids has become a growing problem across the country in recent years. According to the Centers for Disease Control and Prevention, more than 36,000 people died from drug overdoses, most of them from prescription drugs, and three-fourths of prescription drug overdoses are caused by opioid painkillers. The rise in overdose deaths in the United States has run parallel to the 300% increase since 1999 in the sale of opioid painkillers, which were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined. They were further responsible for more than 475,000 emergency department visits in 2009.
To combat abuse, some drug makers have sought to make opioid painkillers tamper-resistant to prevent them from being ground or dissolved for snorting or injection. Examples of drugs that have been changed in this way include Purdue Pharma’s OxyContin (oxycodone) extended-release tablets and Endo’s Opana ER (oxymorphone).
Nevertheless, pharmacy groups say rescheduling hydrocodone could have the unintended side effect of making it harder to get for patients using it for legitimate purposes. In a statement Friday, the National Community Pharmacists Association, while supporting the FDA’s intent, said the move to restrict the drug could be harmful to patients. In the past, the NCPA has suggested that the federal government instead use such strategies as electronic prescription drug monitoring programs and tracking systems.
"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 settings," NCPA B. Douglas Hoey said. "Community pharmacists support aggressive efforts to combat the abuse and diversion of prescription drugs. Such abuse has ruined lives, devastated families and fostered dangerous crimes against pharmacies. At the same time, there are more practical means available to reduce prescription drug abuse."
The National Association of Chain Drug Stores echoed the NCPA’s views.
"Pharmacies have a zero tolerance for prescription drug abuse and a 100% commitment to patient care," the NACDS’ statement read. "This proposal is not the best avenue to address abuse and would negatively impact access to needed medications for those who suffer from chronic pain. In the interest of patient care, we have worked with patient advocacy groups in opposition to this recommendation as we support and advance workable solutions."
APhA, NACDS, NCPA join biosimilar naming debate
NEW YORK — Three pharmacy groups are petitioning the World Health Organization to uphold common generic names for biosimilars and their branded reference products.
In a letter to the WHO sent in conjunction with the 57th Individual Nonproprietary Name Consultation, which ended Thursday, the American Pharmacists Association, the National Association of Chain Drug Stores and the National Community Pharmacists Association said they were "concerned" about efforts to give biosimilars different generic names from their branded counterparts.
"The proposal surrounding a word identifier plus a fantasy suffix, or a two-part name, is concerning to our organizations," read the letter, addressed to INN program manager Balocco Mattavelli and signed by APhA SVP pharmacy practice and government affairs Stacie Maass, NACDS VP public policy and regulatory affairs Kevin Nicholson and NCPA VP policy and regulatory affairs Ronna Hauser. "To avoid a naming convention that may create confusion, our organizations have previously recommended that biosimilar products maintain the same name as their reference biologic counterparts and not use suffixes."
The generic names used for biosimilars have emerged as a contentious issue as the Food and Drug Administration prepares to implement the abbreviated regulatory approval pathway for them, as mandated by the Patient Protection and Affordable Care Act of 2010. Biotech companies, which stand to lose billions in sales when cheaper biosimilar versions of their products enter the market, maintain that because biosimilars will be made using separate cell lines from their branded counterparts, there is a risk that they will be different in terms of safety and efficacy, but generic drug makers reject these claims, pointing to the six years in which biosimilars have been available in the European market.
Also, in a paper recently presented to the WHO, Hospira SVP and chief scientific officer Sumant Ramachandra noted that European regulators had approved biosimilars with the same generic names as their reference biologics for more than six years in a system that had proved effective.
FDA Antiviral Drugs Advisory Committee recommends approval for J&J hepatitis C drug
NEW YORK — A Food and Drug Administration expert panel has recommended approval for a drug made by Johnson & Johnson for treating hepatitis C, the company said.
J&J subsidiary Janssen Research & Development said the 19-member FDA Antiviral Drugs Advisory Committee voted unanimously to recommend approval for TMC435 (simeprevir), a 150-mg drug meant for administration once per day with the generic antiviral ribavirin and a biotech drug known as an interferon, for treating genotype 1 chronic hepatitis C.
"We are pleased with the positive recommendation from the advisory committee for simeprevir and appreciate the rigorous review of our data," Janssen medical department head for infectious diseases Katia Boven said. "It is our hope that the FDA will consider this recommendation and, upon completion of its review process, make simeprevir available to patients with genotype 1 chronic hepatitis C."