Content about Regulatory and Washington

February 7, 2012

The National Retail Federation is taking its "Retail Means Jobs" campaign one step further with the launch of a video contest.

WASHINGTON — The National Retail Federation is taking its "Retail Means Jobs" campaign one step further with the launch of a video contest.

The "This is Retail" video contest looks to highlight the important role retail plays in the U.S. economy by offering a variety of career choices and employment opportunities, NRF said. Retail employees or business owners can submit a two-minute video sharing their retail story; winners of the contest will be awarded $50,000.

February 7, 2012

Two members of Congress are looking for co-sponsors for a bill that would strengthen the medication therapy management benefit in the Medicare prescription drug program.

NEW YORK — Two members of Congress are looking for co-sponsors for a bill that would strengthen the medication therapy management benefit in the Medicare prescription drug program.

Last year, Rep. Mike Ross, D-Ala.; and Cathy McMorris Rodgers, R-Wash., introduced H.R. 891, the Medication Therapy Management Benefits Act, which would allow elderly people with at least one chronic condition access to Medicare Part D coverage for MTM. Currently, only those with multiple conditions are eligible.

February 6, 2012

In the five years since he has led the National Association of Chain Drug Stores, president and CEO Steve Anderson has operated under a sound policy; so simple, it is the advice he gives his own children: “We don’t start any fights — but we sure are going to finish them.” On Monday, Anderson and NACDS chairman Bob Loeffler, who also serves as H-E-B chief administrative officer, told NACDS Regional Chain Conference attendees that now they are going to take that fight to the PBM lobby.

NAPLES, Fla. — In the five years since he has led the National Association of Chain Drug Stores, president and CEO Steve Anderson has operated under a sound policy; so simple, it is the advice he gives his own children: “We don’t start any fights — but we sure are going to finish them.” On Monday, Anderson and NACDS chairman Bob Loeffler, who also serves as H-E-B chief administrative officer, told NACDS Regional Chain Conference attendees here, that now they are going to take that fight to the PBM lobby.

February 3, 2012

The Department of Defense investigation's of a sports supplement ingredient — associated with the death of two soldiers — has been making headlines in the past week as the U.S. Military's independent paper Stars & Stripes ran an update of the news on Jan. 29 and the New York Times picked up on the story Feb. 2.

DALLAS — The Department of Defense's investigation of a sports supplement ingredient — associated with the death of two soldiers — has been making headlines in the past week as the U.S. Military's independent paper Stars & Stripes ran an update of the news on Jan. 29 and the New York Times picked up on the story Feb. 2. 

February 3, 2012

The regulatory waiting period standing between Bristol-Myers Squibb and its acquisition of drug maker Inhibitex has expired, giving Bristol the green light to buy the company.

NEW YORK — The regulatory waiting period standing between Bristol-Myers Squibb and its acquisition of drug maker Inhibitex has expired, giving Bristol the green light to buy the company.

Bristol said Friday that the expiration of the waiting period, mandated by the Hart-Scott-Rodino Antitrust Improvement Act of 1976, would allow it to acquire Inhibitex for $26 per share.

February 2, 2012

The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said Thursday.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said Thursday.

Merck announced the approval of Janumet XR (sitagliptin and metformin hydrochloride) extended-release tablets as a once-daily treatment for the disease.

February 2, 2012

The Food and Drug Administration has given tentative approval to a generic cholesterol drug made by Mylan, the drug maker said Thursday.

PITTSBURGH — The Food and Drug Administration has given tentative approval to a generic cholesterol drug made by Mylan, the drug maker said Thursday.

Mylan announced that it had received tentative approval for a generic version of Pfizer's Lipitor (atorvastatin calcium) in the 10-mg, 20-mg, 40-mg and 80-mg strengths.

February 2, 2012

More than 50 drugs are under development for treating a respiratory disease that is the third-leading cause of death in the United States.

WASHINGTON — More than 50 drugs are under development for treating a respiratory disease that is the third-leading cause of death in the United States.

The Pharmaceutical Research and Manufacturers of America released a list Thursday of 54 drugs in clinical development for chronic obstructive pulmonary disease, or COPD.

February 2, 2012

Medicare Part D plans that had incorporated Walgreens into their network gained market share last year, while those without Walgreens collectively lost market share, according to a Walgreens statement issued Wednesday.

DEERFIELD, Ill. — Medicare Part D plans that had incorporated Walgreens into their network gained market share last year, while those without Walgreens collectively lost market share, according to a Walgreens statement issued Wednesday.

February 1, 2012

A projection issued by the Congressional Budget Office concluded that healthcare spending in the United States would reach a substantial high.

WASHINGTON — A projection issued by the Congressional Budget Office concluded that healthcare spending in the United States would reach a substantial high.

February 1, 2012

The Food and Drug Administration has approved a drug made by Novartis that is designed to prevent tumors in the gastrointestinal tract from recurring after surgical removal, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Novartis that is designed to prevent tumors in the gastrointestinal tract from recurring after surgical removal, the agency said.

The FDA approved Novartis' Gleevec (imatinib) for adults who have had gastrointestinal stromal tumors, or GIST, removed. The drug was specifically approved for people whose tumors are known as CD117-positive, which includes 95% of all GIST tumors.

The drug was originally approved in 2001 for a type of leukemia.

February 1, 2012

The charitable arm of the National Association of Chain Drug Stores once again has released funding that will support 15 new residencies for recent pharmacy graduates.

ALEXANDRIA, Va. — The charitable arm of the National Association of Chain Drug Stores once again has released funding that will support 15 new residencies for recent pharmacy graduates.

January 31, 2012

The Food and Drug Administration has approved a generic drug for anxiety made by Hi-Tech Pharmacal, the drug maker said Tuesday.

AMITYVILLE, N.Y. — The Food and Drug Administration has approved a generic drug for anxiety made by Hi-Tech Pharmacal, the drug maker said Tuesday.

The FDA approved Hi-Tech's lorazepam oral concentrate in the 2-mg-per-mL strength, a generic version of Roxanne Labs' Intensol.

Branded and generic versions of the drug had sales of $10 million in 2011, according to IMS Health.


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January 31, 2012

The Food and Drug Administration has approved a generic drug for obesity made by Lannett, the drug maker said Tuesday.

PHILADELPHIA — The Food and Drug Administration has approved a generic drug for obesity made by Lannett, the drug maker said Tuesday.

Lannett announced the approval of phentermine hydrochloride capsules in the 15-mg strength.

Various versions of the drug had sales of $11 million at average wholesale price in 2011, according to Wolters Kluwer.


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January 31, 2012

The Food and Drug Administration has approved a new treatment for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim, the drug makers said.

INDIANAPOLIS — The Food and Drug Administration has approved a new treatment for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim, the drug makers said.

The FDA approved Jentadueto (linagliptin and metformin) tablets, designed to be taken twice daily. The approval marks the second since the two companies announced their collaboration to develop diabetes drugs in January 2011; the first drug approved under the Lilly-BI partnership was Tradjenta (linagliptin), approved in May 2011.

January 31, 2012

The Food and Drug Administration has approved a drug made by Vertex Pharmaceuticals for treating a rare form of cystic fibrosis, the agency said Tuesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Vertex Pharmaceuticals for treating a rare form of cystic fibrosis, the agency said Tuesday.

The FDA announced the approval of Kalydeco (ivacaftor) for treating patients ages 6 years and older with CF who have a mutation called G551D in the cystic fibrosis transmembrane regulator gene.

January 31, 2012

For every dollar spent on over-the-counter medicines, the U.S. healthcare system realizes a savings of between $6 and $7, or $102 billion all told, the Consumer Healthcare Products Association announced Tuesday with the release of this new study, "The Value of OTC Medicine to the United States."

WASHINGTON — For every dollar spent on over-the-counter medicines, the U.S. healthcare system realizes a savings of between $6 and $7, or $102 billion all told, the Consumer Healthcare Products Association announced Tuesday with the release of this new study, "The Value of OTC Medicine to the United States."

January 31, 2012

Johnson & Johnson Consumer Cos. last week voluntarily recalled from retailers one lot of Aveeno Baby Calming Comfort lotion that was distributed in Alabama, Arkansas, Florida, Georgia, Kansas, Louisiana, Mississippi, Tennessee and Texas.

NEW BRUNSWICK, N.J. — Johnson & Johnson Consumer Cos. last week voluntarily recalled from retailers one lot of Aveeno Baby Calming Comfort lotion that was distributed in Alabama, Arkansas, Florida, Georgia, Kansas, Louisiana, Mississippi, Tennessee and Texas.

This is not a consumer level recall and no action is required by consumers, the company stated.

January 31, 2012

California state officials tentatively are blocked from moving forward with a 10% Medi-Cal reimbursement rate cut.

SACRAMENTO, Calif. — California state officials tentatively are blocked from moving forward with a 10% Medi-Cal reimbursement rate cut.

The court decision, handed down by Judge Christina Snyder, was applauded by several organizations, including the California Medical Association, the California Dental Association, the National Association of Chain Drug Stores, the California Association of Medical Product Suppliers, the AIDS Healthcare Foundation and the American Medical Response.

January 31, 2012

The charitable arm of the National Association of Chain Drug Stores has announced the 2011 recipients of its pharmacy student scholarship awards.

ALEXANDRIA, Va. — The charitable arm of the National Association of Chain Drug Stores has announced the 2011 recipients of its pharmacy student scholarship awards.

The NACDS Foundation said a total of 58 scholarships were awarded, representing 42 colleges and schools of pharmacy.

January 31, 2012

The Natural Products Association last week announced it will host its 15th Annual Natural Products Day to help educate policy-makers on the value of dietary supplements here on March 27.

WASHINGTON — The Natural Products Association last week announced it will host its 15th Annual Natural Products Day to help educate policy-makers on the value of dietary supplements here on March 27.

The day begins with an issue briefing and advocacy training so attendees learn how they can participate in the policy-making process and advocate for their interests. Afterwards, pre-arranged meetings at congressional offices offer the chance to talk to senators, representatives and their staffs about key legislation and regulatory activities.

January 31, 2012

A goal to standardize risk evaluation and mitigation strategies and modernize the U.S. drug safety system in a proposed reauthorization of the Prescription Drug User Fee Act has drawn support from the country's main chain retail pharmacy lobby.

ALEXANDRIA, Va. — A goal to standardize risk evaluation and mitigation strategies and modernize the U.S. drug safety system in a proposed reauthorization of the Prescription Drug User Fee Act has drawn support from the country's main chain retail pharmacy lobby.

The National Association of Chain Drug Stores submitted written testimony Tuesday ahead of a congressional hearing on the reauthorization of PDUFA, originally enacted in 1992.

January 30, 2012

The Food and Drug Administration has approved a long-acting injected diabetes drug made by Amylin Pharmaceuticals and Alkermes, the two companies said.

SAN DIEGO — The Food and Drug Administration has approved a long-acting injected diabetes drug made by Amylin Pharmaceuticals and Alkermes, the two companies said.

The FDA approved Bydureon (exenatide), which the companies called the first once-weekly treatment for Type 2 diabetes. The drug will become available in February.

January 30, 2012

The FDA announced the approval of Genentech's Erivedge (vismodegib) for adults with basal cell carcinoma who are not surgery or radiation therapy candidates and whose disease is locally advanced or has spread to other parts of the body.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating the most common type of skin cancer, the agency said Monday.

The FDA announced the approval of Genentech's Erivedge (vismodegib) for adults with basal cell carcinoma who are not surgery or radiation therapy candidates and whose disease is locally advanced or has spread to other parts of the body.

January 30, 2012

Lannett announced that it has received approval from the Food and Drug Administration to market its version of a hypertension treatment.

PHILADELPHIA — Lannett announced that it has received approval from the Food and Drug Administration to market its version of a hypertension treatment.

The drug maker said its abbreviated new drug application for hydrochlorothiazide capsules in the 12.5-mg strength was approved. The drug is a generic version of Watson Pharmaceuticals' Microzide capsules.