DEA pushes forward on rescheduling hydrocodone combination products
WASHINGTON — In what could turn into a significant change of how retail pharmacy supplies hydrocodone combination products, the Drug Enforcement Administration last week published in the Federal Register a Notice of Proposed Rulemaking to move HCPs from Schedule III to Schedule II, as recommended by the assistant secretary for Health of the department of Health and Human Services and as supported by the DEA’s evaluation of relevant data.
However, the move may severely restrict access to necessary pain medication for legitimate patients. For patients, reclassifying hydrocodone compounds as a schedule II substance would require them to make a doctor’s visit every time they need a prescription. Refills of schedule II drugs are not permissible; and the prescriptions have to be original copies. That represents a cost barrier for many pain sufferers.
The rescheduling of hydrocodone compounds also will have repercussions up and down the supply chain, in large part because of the sheer volume of prescriptions that would be reclassified. In 2012, pain was the No. 2 most-prescribed therapeutic class of medicines, with 472 million prescriptions written, according to IMS Health. The most-prescribed medicine for the year was hydrocodone/acetaminophen, with 135.3 million prescriptions written for the pain-relieving compound.
At the wholesale level, schedule II substances have to be stored in a locked vault vs. being restricted to a caged area, meaning drug distributors would need to make wholesale capital investments in expanding their vault space. And retailers would likewise need to invest in larger security storage units in an effort to be compliant with the new schedule.
The speculation among retail pharmacy experts is that the increase in investment could force many pharmacies, especially smaller community pharmacies serving rural patients, to reconsider carrying HCPs.
Members of the public are invited to submit comments or request a hearing through www.regulations.gov. Electronic comments must be submitted, or written comments postmarked, by 11:59 p.m. EST on April 27. Requests for hearings must be submitted by March 31, the DEA noted.
Once the public comment period has closed and the DEA has considered all comments, the DEA will publish a Final Rule in the Federal Register.
The rescheduling of HCPs was initiated by a petition from a physician in 1999. The DEA submitted a request to HHS for a scientific and medical evaluation of HCPs and a scheduling recommendation.
In 2013, the Food and Drug Administration held a public Advisory Committee meeting on the matter, and the committee voted to recommend rescheduling HCPs from Schedule III to Schedule II by a vote of 19 to 10. With the receipt of that recommendation, the DEA initiated the formal rulemaking process by publishing a notice and soliciting public comments.
Dr. Reddy’s launches moxifloxacin tablets
HYDERABAD, India — Dr. Reddy’s Labs announced the launch of moxifloxacin hydrochloride tablets, the generic version of Avelox tablets, in 400-mg form. The drug is available in bottle counts of 30.
Avelox tablets had U.S. sales of approximately $195 million for the 12 months ending in December 2013, according to IMS Health.
Merz North America names new VP managed markets
GREENSBORO, N.C. — Merz North America on Tuesday announced the appointment of Gregory Bass as VP managed markets. In this role, Bass will primarily be responsible for developing Merz’s North American market access and reimbursement strategy to enhance patient access to Merz prescription products. Bass will join Merz’s North America leadership team and will report directly to Bill Humphries, president and CEO of Merz North America.
"Greg brings broad experience in the industry across multiple specialties, including oncology, immunology, dermatology and neurology," Humphries said. "Greg’s success in previous sales, marketing and managed market roles, along with his reputation for driving team performance and strategic results makes him an ideal fit for a growing and customer-focused company like Merz."
Prior to joining Merz, Bass held the position of senior director, managed markets at Johnson & Johnson Healthcare Systems. Under his leadership, that team managed and grew a $6 billion portfolio of immunology and oncology products.
Bass has more than 17 years of experience in the pharmaceutical and biopharmaceutical industries and holds a Bachelor of Arts degree in Biology from Brandeis University in Waltham, Mass. Bass will be based out of Merz’s North American headquarters.