Licensing

ALLEGAN, Mich. — Perrigo Co. has hired a former Food and Drug Administration official for its regulatory department, the drug maker said Friday.

The Allegan, Mich.-based drug maker announced the appointment of Keith Webber as head of regulatory review, a position in which he will start on Oct. 21. Webber previously served as acting director of the FDA's Office of Pharmaceutical Science, part of the Center for Drug Evaluation and Research, which regulates prescription and OTC drugs. He also served as director of the Office of Generic Drugs.

Countless industries are continuously updating and retooling their approaches to production, organization, communication, training and other systemic procedures to keep up with ever-changing landscapes. The specialty pharmacy industry is no different and, in fact, has reached a critical point when it comes to training, qualifying and educating the growing number of pharmacists practicing in this complex area.

Results from a nationwide survey last year revealed that adults get immunized in pharmacies more frequently than anywhere else, other than physician offices. This should come as no surprise considering the convenient hours, ease of access and frequency of visits to pharmacies. But what is the legal status of pharmacy-based immunization, and what are the roles of the pharmacist?

Status of pharmacist immunizers

PARSIPPANY, N.J. — Actavis has launched a generic drug for post-shingles pain under an agreement with the branded drug's manufacturers, the company said Monday.

Actavis announced the launch of generic lidocaine topical patches in the 5% strength under a settlement agreement with Endo Pharmaceuticals and Teikoku Seiyaku Co. The drug is a generic version of Lidoderm, and Actavis said it was likely the first company to win approval for the generic from the Food and Drug Administration, thus entitling it to 180 days in which to compete exclusively against the branded version.

WASHINGTON — The news that the Food and Drug Administration exceeded its hiring goals for a push that began last year to speed up review of generic drug approval applications is music to the ears of a trade group representing the industry.

SILVER SPRINGS, Md. — The Food and Drug Administration has exceeded its goals for hiring new staff as part of a user-fee law for generic drugs, according to an internal memo sent to staff members.

In a memo to staff of the agency's Center for Drug Evaluation and Research, center director Janet Woodcock wrote that for fiscal year 2013, the FDA hired 234 people as part of the Generic Drug User Fee Amendments Human Capital Team. The goal was to hire 231 as part of a three-year push in which it hopes to hire 921, including 461 during fiscal year 2014.

The country's embryonic biosimilars industry scored a victory last month as the organization that runs the pension fund for California state employees announced its opposition to a state Senate bill provision that would impose special requirements on pharmacists who dispense follow-on biologics.

The Food and Drug Administration is raising the fees that generic drug companies will have to pay when filing for regulatory approval for new products or supplemental applications for existing products, the agency said last month.