Pernix, ParaPro to promote prescription pediculicide if approved
MAGNOLIA, Texas — Pernix Therapeutics Holdings on Wednesday announced an exclusive co-promotion agreement with ParaPro for a medication to treat head lice.
A new drug application for the prescription product currently is under review by the Food and Drug Administration. The proposed medication contains the active ingredient spinosad, which is derived from a naturally occurring soil bacterium.
Under the terms of the agreement, if the drug containing spinosad is approved by the FDA, Pernix and ParaPro exclusively will co-promote the medication with a combined sales force in the United States. Pernix would leverage its established pediatric sales force to promote the drug to healthcare professionals who treat human head lice.
If approved, the product is expected to be available in the first half of 2011.
McNeil issues recall at wholesaler level
FORT WASHINGTON, Pa. — In consultation with the Food and Drug Administration, McNeil Consumer Healthcare on Friday voluntarily recalled certain lots of Tylenol 8 Hour, Tylenol Arthritis Pain and Tylenol upper respiratory products, as well as certain lots of Benadryl, Sudafed PE and Sinutab products at the wholesale level.
All of the products were manufactured at the McNeil plant in Fort Washington, Pa., prior to April 2010, when production at the facility was suspended. McNeil stated the company has initiated the recall as a precautionary measure after an extensive review of past production records found instances where equipment-cleaning procedures were insufficient or that cleaning was not adequately documented. However, it is very unlikely that this impacted the quality of these products, McNeil stated.
McNeil also initiated a voluntary recall of certain product lots of Rolaids Multi-Symptom Berry tablets distributed in the United States, in order to update the labeling. The company initiated the recall after determining that the product labeling does not include the language "Does not meet USP" as required by regulation.
Because the recalls are being initiated at the wholesale level, no action is required by consumers or healthcare providers, and consumers can continue to use the product, McNeil stated. These actions are not being undertaken on the basis of adverse events, the company added.
Kentucky introduces PSE Rx legislation
FRANKFORT, Ky. — The battle for the prescription status of methamphetamine precursor/popular cough-cold ingredient pseudoephedrine now is heating up in Kentucky, just a few days following a Nevada news report that suggested the state will be considering PSE prescription-only requirements just as soon as a bill is introduced by Nevada Sen. Sheila Leslie, D-Reno.
Kentucky Reps. Linda Belcher, D-Shepherdsville, and Mary Lou Marzian, D-Louisville, introduced legislation to establish a PSE prescription-only requirement on the first day of the General Assembly — Jan. 4. Kentucky Sen. Tom Jensen, R-London, introduced similar legislation in the Senate.
The Kentucky Legislative Research Commission on Thursday entertained presentations from both sides of the argument, including Mandy Hagan, director of state government relations for the Consumer Healthcare Products Association, who testified on behalf of the industry.
Proponents of the prescription-only solution pointed to the significant reduction in methamphetamine busts in Oregon and Mississippi, two states that currently require prescriptions for PSE purchases, according to a report in the Lexington Herald Leader that covered the meeting.
Proponents of an electronic logging system, such as MethCheck, that currently is up and running in Kentucky, contended that the increase in methamphetamine-related crimes was a direct result of law enforcement’s ability to track PSE sales in real time.
"We are seeing an increase in the number of meth labs [found] because of the information that MethCheck provides," testified Daviess County Sheriff Keith Cain, as reported in the Herald Leader report. "It has proven to be very helpful in tracking individuals who are trying to [buy over-the-counter drugs to produce methamphetamine]."
If pseudoephedrine requires a prescription in the future, buyers would be tracked in Kentucky by the All Schedule Prescription Electronic Reporting system, or KASPER, which tracks every prescription for controlled substances written in the state, Cain continued. There typically is a lag of several days for KASPER reports, compared with the real-time reporting capabilities associated with MethCheck.
However, Kentucky State Police Major Joe Williams testified that most of the meth labs found in Kentucky were not uncovered using MethCheck.
According to the Herald Leader report, Kentucky’s meth lab incidents totaled more than 1,000 in 2010. A report released by the legislature’s Program Review and Investigations Committee identified a 70% decline in the number of meth lab incidents in Mississippi.