Mark Lowery an Editor for Drug Topics magazine.

Mark Lowery, Editor

	Sandoz has announced the U.S. launch of an authorized generic version of PharmaDerm’s Solaraze Gel (diclofenac 3% gel), which generated $92 million in 2012. 

	Diclofenac 3% gel is an approved topical treatment of actinic keratosis, a precancerous condition of thick, scaly, or crusty patches of skin that affects an estimated 58 million Americans. Sandoz will market its diclofenac gel in the 3% strength.

	“As the global leader across a broad range of differentiated generic categories, Sandoz is pleased to offer a high-quality generic version of this important medicine to U.S. patients,” said Peter Goldschmidt, president of Sandoz US. “This important launch further strengthens our U.S. and global leadership in topical generic dermatology.”

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Sandoz has announced the U.S. launch of an authorized generic version of PharmaDerm’s Solaraze Gel (diclofenac 3% gel), which generated $92 million in 2012.

Sandoz to offer generic Solaraze

	Congressional action to tighten regulations for compounding pharmacies will not prevent another tragedy such as last year’s fungal meningitis outbreak, according to the Academy of Managed Care Pharmacy (AMCP).

	Last week, the U.S. Senate approved tighter regulations for compounding pharmacies and created a national system that tracks prescription drugs from manufacturers to pharmacies. The legislative action came a year after contaminated steroids from the now closed New England Compounding Center in Massachusetts killed 64 people and sickened more than 750 others across the United States.

	AMCP said it welcomes the strengthening of the drug distribution chain, but that the legislation did not go far enough to guarantee strict regulation of compounders.

	“We're very concerned that the bill's voluntary registration scheme will not achieve the main goal – to protect the public from the unauthorized compounding of drugs. Simply put, the ‘outsourcing facility’ created under the bill will not be required to register with the FDA,” said AMCP CEO Edith A. Rosato, RPh, IOM. “With the bill's limited scope, only those facilities that volunteer to register will be subject to the FDA, which will leave the public no better off. Facilities that compound drugs, are not licensed pharmacies and choose not to register with the FDA will continue to ‘escape’ regulation and oversight,” she said.

	AMCP also criticized another loophole in the bill. The new regulations allow a licensed pharmacy, which is already regulated by state pharmacy boards, that registers as an “outsourcing facility” to be subject to FDA regulation. “We believe this dual regulatory scheme will lead to administration and regulatory confusion, creating opportunities for gaps in responsibility and accountability,” Rosato said.

Congressional action to tighten regulations for compounding pharmacies will not prevent another tragedy such as last year’s fungal meningitis outbreak, according to the Academy of Managed Care Pharmacy.

New compounding rules won’t prevent another tragedy, AMCP says

 birthday at the beach, pharmacist Roger Harris returned to his Anniston, Ala. workplace to find a surprise waiting for him: He had been fired and replaced by a 27 year-old.

	Harris sued CVS Caremark, alleging the retail chain violated the federal Age Discrimination Employment Act when it fired him in 2009. And after a two-week jury trial before U.S. District Court Judge Virginia Hopkins, a federal jury agreed with Harris and awarded him $400,000 in back pay. Harris could be eligible for an additional $400,000 in damages. Judge Hopkins has yet to rule on damages.

	"The termination document was dated August 13, 2009," said Kenneth Haynes, Harris’ lawyer, told the 

 "He was celebrating his 65th birthday at the beach. When he returned to work he was informed on August 17, 2009 of his termination."

	A CVS spokesman said the chain is considering an appeal.

	"We respect and appreciate the jury's effort in reviewing this case, but we strongly disagree with their decision," Mike DeAngelis, CVS Caremark’s director public relations told the newspaper. "CVS Caremark has a firm non-discrimination policy, and we do not tolerate discrimination in our workplace on the basis of age or any other legally-protected trait.  We are considering our options for appeal."

After celebrating his 65th birthday at the beach, pharmacist Roger Harris returned to his Anniston, Ala. workplace to find a surprise waiting for him: He had been fired and replaced by a 27 year-old.

Pharmacist wins age discrimination case against CVS

	FDA has approved the supplemental New Drug Application for tofacitinib citrate (Xeljanz, Pfizer) to include additional patient-reported outcomes data on the label.

	"The patient-reported outcomes data show the impact that Xeljanz can have on the daily lives of patients with rheumatoid arthritis, based on physical, mental and emotional measures," said Steven Romano, senior vice president and the head of the medicines development group for Pfizer Specialty Care.

	Last year, FDA approved tofacitinib 5 mg twice-daily for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The janus kinase inhibitor can be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying anti-rheumatic drugs.

	Pfizer said the new data from three phase 3 studies show improvement in patients receiving tofacitinib based on health-related outcome measures reported by patients, including vitality, role emotional, physical function, bodily pain, social function, mental health, role physical and general health.

FDA has approved the supplemental New Drug Application for tofacitinib citrate (Xeljanz, Pfizer) to include additional patient-reported outcomes data on the label.

New outcomes data to be included on Xeljanz labels

	The Michigan Senate has approved a bill that would allow medical marijuana to be dispensed by pharmacies throughout the state. However, the vote by the Michigan senators is merely symbolic, as FDA would have to reclassify marijuana as Schedule II to allow such dispensing.

	The Michigan legislation reclassifies medical-grade marijuana as a Schedule II controlled substance, which would clear the way for pharmacies to dispense it. FDA lists marijuana as a Schedule I drug, along with heroin, peyote, and LSD, which have no accepted medical use and a high potential for abuse. The bill also authorizes private facilities to grow and test the cannabis.

	The Michigan bill was sponsored by Sen. Roger Kahn (R-Saginaw), a doctor who said patients using medical marijuana under the state’s 2008 law should have more ways of obtaining it. Right now, Michigan patients using medical marijuana obtain it from state-licensed growers.

	“The idea is now that marijuana is considered a medicine ... there should be a medically reviewed way to get the product,” Sen. Kahn 

. “Despite its initial presentation to our people as ‘medical,’ Michigan’s constitutional (marijuana) provision contains no patient protection standards and, in particular, no standards that will protect immunosuppressed patients from molds, pesticides, metals, or other contaminants commonly present in marijuana.”

	Sen. Gretchen Whitmer (D-East Lansing) said Kahn’s real motivation was creating a business opportunity for Prairie Plant Systems, a Canadian biotechnology firm that produces medical marijuana.

	“Since the passage of the public referendum to legalize marijuana for medical use in 2008, the Michigan legislature has tried and failed to regulate the industry in a way that accommodates patients while appeasing social conservatives,” Sen. Whitmer said. “The end result has been constant confusion and legal ambiguity and an array of red tape that has impeded Michigan’s sick from getting the treatment they need.”

	The Michigan Pharmacists Association did not take a position on the legislation. It issued a statement that partially read: “Unlike other prescription medications that pharmacists provide for patients, marijuana has not gone through the rigorous studies on safety and effectiveness required to be approved by the FDA.”

The Michigan Senate has approved a bill that would allow medical marijuana to be dispensed by pharmacies throughout the state. However, the vote by the Michigan senators is merely symbolic, as FDA would have to reclassify marijuana as Schedule II to allow such dispensing.

Michigan bill calls for pharmacy medical marijuana dispensing

	Walgreens has donated $100,000 to the American Red Cross for Typhoon Haiyan disaster-relief efforts.

	The money will be used to distribute relief items, repair and rebuild shelters, provide health care, and give access to clean water and sanitation systems for those impacted by the storm. Thousands were killed by the typhoon that ravished the Philippines last week.

	“Thousands of people in the Philippines have been left without basic living needs, so we are supporting the American Red Cross to help bring aid to those who need it the most. Our thoughts go out to all of those impacted by this disaster,” said John Gremer, Walgreens director of community affairs.

Walgreens has donated $100,000 to the American Red Cross for Typhoon Haiyan disaster-relief efforts.