Content about Regulatory and Washington

April 24, 2012

The National Retail Federation has named Bill Thorne SVP communications and public affairs.

WASHINGTON — The National Retail Federation has named Bill Thorne SVP communications and public affairs. He will join NRF on June 1 to oversee the organization's industry and public affairs communications strategy, including NRF's "Retail Means Jobs" campaign, a multimillion dollar initiative to demonstrate the power of retail to America’s economy and the career opportunities within the industry.

Thorne currently serves as senior director of community affairs at Walmart.

April 23, 2012

The National Association of Chain Drug Stores has elected new officers for the coming year.

PALM BEACH, Fla. — The National Association of Chain Drug Stores has elected new officers for the coming year.

For the 2012-2013 term, NACDS chairman Bob Loeffler, who also serves as chief administrative officer of H-E-B, will be succeeded by Walgreens president and CEO Greg Wasson. Thrifty White Pharmacy president and CEO Bob Narveson was elected as vice chairman, while Rite Aid president and CEO John Standley was appointed as treasurer, as well as a member of NACDS' executive committee. Wasson, Narveson and Standley will serve one-year terms.

April 23, 2012

Par Pharmaceutical has bought rights to a generic drug for gastroesophageal reflux disease from Handa Pharmaceuticals, Par said.

WOODCLIFF LAKE, N.J. — Par Pharmaceutical has bought rights to a generic drug for gastroesophageal reflux disease from Handa Pharmaceuticals, Par said.

Handa, based in Fremont, Calif., sold rights to the regulatory approval application it filed with the Food and Drug Administration for dexlansoprazole capsules, a generic version of Takeda's Dexilant, in the 60-mg strength.

April 22, 2012

Steve Anderson recalled during Sunday morning’s State of the Association address how when he started as the president and CEO of the National Association of Chain Drug Stores five years ago, people were interested to see what his eyes would discover at NACDS and within community pharmacy that might help make a difference for the future. Anderson said that today he answers that question in the same way he did back then: “Every day my eyes see something fresh in what you do — in the innovative offerings of community pharmacy.”

PALM BEACH, Fla. — Steve Anderson recalled during Sunday morning’s State of the Association address how when he started as the president and CEO of the National Association of Chain Drug Stores five years ago, people were interested to see what his eyes would discover at NACDS and within community pharmacy that might help make a difference for the future. Anderson said that today he answers that question in the same way he did back then: “Every day my eyes see something fresh in what you do — in the innovative offerings of community pharmacy.”

April 22, 2012

As Greg Wasson, president and CEO of Walgreens, settles into his new role as incoming chairman of NACDS, Drug Store News caught up with him to get his thoughts on his new role and his industry perspectives.

As Greg Wasson, president and CEO of Walgreens, settles into his new role as incoming chairman of the National Association of Chain Drug Stores, Drug Store News caught up with him to get his thoughts on his new role and his industry perspectives.

DSN:
As incoming chairman, what is your first order of business?

April 21, 2012

Bob Loeffler, NACDS chairman and chief administrative officer of H-E-B, reflects on his time as chairman and shares his insights on the issues facing retail pharmacy today and tomorrow.

Bob Loeffler, NACDS chairman and chief administrative officer of H-E-B, reflects on his time as chairman and shares his insights on the issues facing retail pharmacy today and tomorrow.

DSN: Last year, you emphasized the “new normal,” which seemed to refer to the need to proactively position the benefits of retail pharmacy. How has the “new normal” played out?

April 20, 2012

As the industry geared up for this year’s National Association of Chain Drug Stores Annual Meeting, Drug Store News talked with NACDS president and CEO Steve Anderson about the hottest issues facing pharmacy and his thoughts on the 2012 presidential election.

As the industry geared up for this year’s National Association of Chain Drug Stores Annual Meeting, Drug Store News talked with NACDS president and CEO Steve Anderson about the hottest issues facing pharmacy and his thoughts on the 2012 presidential election.

Drug Store News: What do you think will be the hot-button issues that will be top of mind at this year’s Annual Meeting?

April 20, 2012

Despite achieving measles elimination in 2000, the Centers for Disease Control and Prevention reported in its "Morbidity and Morality Weekly Report" that a total of 222 measles cases and 17 measles outbreaks were reported to the CDC last year, compared with a median of 60 cases and four outbreaks reported annually during the 2001-2010 period.

ATLANTA — Despite achieving measles elimination in 2000, the Centers for Disease Control and Prevention reported in its "Morbidity and Morality Weekly Report" that a total of 222 measles cases and 17 measles outbreaks were reported to the CDC last year, compared with a median of 60 cases and four outbreaks reported annually during the 2001-2010 period.

In the United States, the incidence of measles has reached a 15-year high, the CDC said.

April 20, 2012

Regulators have approved a new blood-glucose monitoring system made by Bayer HealthCare, the company said.

TARRYTOWN, N.Y. — Regulators have approved a new blood-glucose monitoring system made by Bayer HealthCare, the company said.

Bayer announced the Food and Drug Administration's approval of Contour Next EZ, which includes a meter and test strip sensors that the company said would improve accuracy.

Bayer said the system is being introduced on a market-by-market basis and will be available in the United States this summer.

April 19, 2012

The U.S. District Court for the Western District of Pennsylvania on Wednesday accepted an amici curiae from the Consumer Federation of America, the National Consumers League, the National Legislative Association on Prescription Drug Prices and U.S. PIRG (a federation of 28 nonprofit, nonpartisan state Public Interest Research Groups) on behalf of retail pharmacy plaintiffs in their suit to dismantle the Express Scripts-Medco merger.

PITTSBURGH — The U.S. District Court for the Western District of Pennsylvania on Wednesday accepted an amici curiae from the Consumer Federation of America, the National Consumers League, the National Legislative Association on Prescription Drug Prices and U.S. PIRG (a federation of 28 nonprofit, nonpartisan state Public Interest Research Groups) on behalf of retail pharmacy plaintiffs in their suit to dismantle the Express Scripts-Medco merger.

April 19, 2012

A trade organization representing generic drug manufacturers announced Thursday its latest solution to the problem of drug shortages.

WASHINGTON — A trade organization representing generic drug manufacturers announced Thursday its latest solution to the problem of drug shortages.

April 19, 2012

In anticipation of its 2012 Legislative Conference next month, the National Community Pharmacists Association unveiled its lineup of congressional speakers who will discuss pressing healthcare and pharmacy issues with pharmacists.

ALEXANDRIA, Va. — In anticipation of its 2012 Legislative Conference next month, the National Community Pharmacists Association unveiled its lineup of congressional speakers who will discuss pressing healthcare and pharmacy issues with pharmacists.

April 19, 2012

The Personal Care Products Council and the Safe Cosmetics Alliance has announced support for legislation to strengthen and modernize regulatory oversight of the industry and to create a greater role for the Food and Drug Administration in assessing the safety of personal care products.

WASHINGTON — The Personal Care Products Council and the Safe Cosmetics Alliance has announced support for legislation to strengthen and modernize regulatory oversight of the industry and to create a greater role for the Food and Drug Administration in assessing the safety of personal care products.

April 19, 2012

SXC Health Solutions and Catalyst Health Solutions on Wednesday announced a merger agreement under which SXC and Catalyst will combine in a cash and stock transaction valued at approximately $4.4 billion.

LISLE, Ill. — SXC Health Solutions and Catalyst Health Solutions on Wednesday announced a merger agreement under which SXC and Catalyst will combine in a cash and stock transaction valued at approximately $4.4 billion. The announcement comes some three weeks after Express Scripts and Medco consummated their $29.1 billion merger.

April 19, 2012

Generic drug maker Watson is challenging the patent protection on a drug used to treat Type 2 diabetes.

PARSIPPANY, N.J. — Generic drug maker Watson is challenging the patent protection on a drug used to treat Type 2 diabetes.

Watson said Thursday that it had filed with the Food and Drug Administration for approval of a generic version of Depomed's Glumetza (metformin hydrochloride extended-release tablets) in the 1,000-mg strength.

April 17, 2012

Two weeks before the Food and Drug Administration met on expanding the switch paradigm, attendees of the Consumer Healthcare Products Association’s Annual Executive Conference discussed how over-the-counter medicines can help shape health care as part of a panel featuring Joe Magnacca, Walgreens president of daily living products and solutions.

BONITA SPRINGS, Fla. — Two weeks before the Food and Drug Administration met on expanding the switch paradigm, attendees of the Consumer Healthcare Products Association’s Annual Executive Conference discussed how over-the-counter medicines can help shape health care as part of a panel featuring Joe Magnacca, Walgreens president of daily living products and solutions.

April 16, 2012

Children under the age of 10 years old may be especially susceptible to a new strain of influenza, according to an article published Friday in the Center for Disease Control and Prevention's "Morbidity and Mortality Weekly Report."

ATLANTA — Children under the age of 10 years old may be especially susceptible to a new strain of influenza, according to an article published Friday in the Center for Disease Control and Prevention's "Morbidity and Mortality Weekly Report."

April 16, 2012

The Food and Drug Administration is requesting additional data from two drug makers for a treatment for immune system disorders.

DEERFIELD, Ill. — The Food and Drug Administration is requesting additional data from two drug makers for a treatment for immune system disorders.

Baxter and Halozyme said the FDA wanted more data to review their application for HyQ, a combination of immune globulin and recombinant human hyaluronidase.

The companies said they would work to develop studies to provide additional data to address the agency's concerns.

 

April 13, 2012

Drug companies invested nearly $50 billion in research and development in 2011, according to a new report by a drug industry trade group.

WASHINGTON — Drug companies invested nearly $50 billion in research and development in 2011, according to a new report by a drug industry trade group.

April 13, 2012

Get set for another decade of explosive growth throughout the over-the-counter category with the familiar switch as a catalyst. 


Get set for another decade of explosive growth throughout the over-the-counter category with the familiar switch as a catalyst. 


The Food and Drug Administration public meeting that took place last month addressed a proposal to expand the switch paradigm by utilizing the latest in communications and diagnostics technology and/or incorporating the most accessible healthcare professional — the retail pharmacist — into the self-care decision protocol. 


April 13, 2012

The Pharmaceutical Research and Manufacturers of America announced Friday the appointment of Eli Lilly chairman, president and CEO John Lechleiter as PhRMA chairman at its annual meeting.

BOSTON — The Pharmaceutical Research and Manufacturers of America announced Friday the appointment of Eli Lilly chairman, president and CEO John Lechleiter as PhRMA chairman at its annual meeting. The group also elected Celgene president and CEO Robert Hugin as chairman-elect of its board of directors and Pfizer president and CEO Ian Read as board treasurer. Lechleiter replaces Sanofi CEO Christopher Viehbacher as chairman.

April 13, 2012

The Food and Drug Administration has approved a generic drug for lipid disorders made by Mylan, the company said Friday.

PITTSBURGH — The Food and Drug Administration has approved a generic drug for lipid disorders made by Mylan, the company said Friday.

Mylan announced the approval and launch of fluvastatin capsules in the 20-mg and 40-mg strengths, a generic version of Novartis' Lescol. The drug is used to treat hypercholesterolemia and mixed dyslipidemia, as well as prevention of cardiovascular disease.

The drug had sales of $27.9 million in 2011, according to IMS Health.

April 13, 2012

Health is about to be made a lot less expensive as the agency explores ways to expand which therapy categories can be made self-selection- and self-care-friendly through communication or diagnostic technology in conjunction with a consultation with a retail healthcare professional. 


Health is what you make of it. And judging from a recent public meeting held by the Food and Drug Administration, health is about to be made a lot less expensive as the agency explores ways to expand which therapy categories can be made self-selection- and self-care-friendly through communication or diagnostic technology in conjunction with a consultation with a retail healthcare professional. 


April 12, 2012

Generic drug maker Impax Labs is challenging the patent protection on a drug used to treat postherpetic neuralgia, the company said Thursday.

HAYWARD, Calif. — Generic drug maker Impax Labs is challenging the patent protection on a drug used to treat postherpetic neuralgia, the company said Thursday.

Impax announced that it had filed a regulatory approval application with the Food and Drug Administration for gabapentin tablets, a generic version of Depomed's Gralise, in the 300-mg and 600-mg strengths.

April 11, 2012

Legislation that requires transparency in the pharmacy audit processes conducted by pharmacy benefit managers is being enacted in Kentucky.

ALEXANDRIA, Va. — Legislation that requires transparency in the pharmacy audit processes conducted by pharmacy benefit managers is being enacted in Kentucky.

H.B. 349, which was signed by Kentucky state governor Steve Beshear last week and sponsored by Senate majority whip Tommy Thompson (D-Ky.), is designed to prohibit PBMs from seeking to recoup payments through pharmacy audits when there is no evidence of fraud.

The signing of the legislation was praised by the National Association of Chain Drug Stores.