Content about Regulatory and Washington

March 19, 2013

A survey of 114 researchers, government officials, insurers, employers, business leaders and trade groups found nearly one-third say comparative effectiveness research will have a "moderate improvement" on healthcare decision making over the next 12 months.

WASHINGTON — A survey of 114 researchers, government officials, insurers, employers, business leaders and trade groups found nearly one-third say comparative effectiveness research will have a "moderate improvement" on healthcare decision making over the next 12 months.

March 19, 2013

The question of whether a generic drug company can be held liable for harmful side effects from its medicines goes before the Supreme Court Tuesday in a case involving a New Hampshire woman who sustained several injuries after taking a generic pain drug.

WASHINGTON — The question of whether a generic drug company can be held liable for harmful side effects from its medicines goes before the Supreme Court Tuesday in a case involving a New Hampshire woman who sustained several injuries after taking a generic pain drug.

March 18, 2013

The Environmental Protection Agency has given Sears Holdings a 2013 Energy Star Partner of the Year - Sustained Excellence Award, the company said Monday.

HOFFMAN ESTATES, Ill. — The Environmental Protection Agency has given Sears Holdings a 2013 Energy Star Partner of the Year - Sustained Excellence Award, the company said Monday.

Sears Holdings, which operates Kmart, said its efforts to promote sustainability and energy efficiency would be recognized at a ceremony in Washington on March 26.

The company has been an Energy Star partner since 1998.

March 18, 2013

The Food and Drug Administration has approved a generic treatment for bronchospasm made by Mylan, the drug maker said Monday.

PITTSBURGH — The Food and Drug Administration has approved a generic treatment for bronchospasm made by Mylan, the drug maker said Monday.

Mylan announced the approval of levalbuterol inhalation solution in the 0.31 mg/3 mL, 0.63 mg/3 mL and 1.25 mg/3 mL strengths. The company has begun shipping the product.

The drug is a generic version of Sunovion's Xopenex inhalation solution, which is used to treat bronchospasm in patients ages 6 years and older with reversible obstructive airway disease.

March 18, 2013

In spite of a court ruling striking down a ban on large-sized sugary drinks, New York mayor Michael Bloomberg has another health initiative in the works: a requirement that retailers hide tobacco products.

NEW YORK — In spite of a court ruling striking down a ban on large-sized sugary drinks, New York mayor Michael Bloomberg has another health initiative in the works: a requirement that retailers hide tobacco products.

Bloomberg's legislation, which would make New York the first city to keep tobacco products out of the sight of customers, will go to the city council for consideration. The New York Times noted that Bloomberg skipped this procedure with the soft drink rule.

March 15, 2013

The Campaign for Tobacco-Free Kids is organizing more than 1,200 events across the country to promote smoking abstinence and cessation.

WASHINGTON — The Campaign for Tobacco-Free Kids is organizing more than 1,200 events across the country to promote smoking abstinence and cessation.

The group announced Friday the 18th annual Kick Butts Day, on March 20, in which young people will encourage peers to stay tobacco-free and educate their communities about the health effects of smoking. While youth smoking rates have gone down, 18.1% of high school students still smoke, the group said.

March 15, 2013

The Food and Drug Administration has approved a new pocket-sized packet option for a testosterone-replacement therapy made by AbbVie, the drug maker said Friday.

CHICAGO — The Food and Drug Administration has approved a new pocket-sized packet option for a testosterone-replacement therapy made by AbbVie, the drug maker said Friday.

AbbVie announced the approval of the new version of AndroGel (testosterone) 1.62%, available in a packet containing 40.5 mg of testosterone in 2.5 g of gel and a packet with 20.25 mg of testosterone in 1.25 g of gel. The drug is used to raise testosterone levels in men with low or no testosterone, known as hypogonadism, estimated to affect nearly 14 million men in the United States.

March 15, 2013

Hostess Brands on Thursday announced that the stalking horse bid submitted by McKee Foods for the Drake's snack cake brand will be presented for approval to the U.S. Bankruptcy Court, as no other qualified bids were received for those assets.

KANSAS CITY, Mo. — Hostess Brands on Thursday announced that the stalking horse bid submitted by McKee Foods for the Drake's snack cake brand will be presented for approval to the U.S. Bankruptcy Court, as no other qualified bids were received for those assets.

McKee has agreed to pay $27.5 million for the Drake's brand and certain equipment. Drake's products include Ring Dings, Yodels, Devil Dogs, Yankee Doodles, Sunny Doodles and Drake's Coffee Cake.

March 15, 2013

The National Association of Chain Drug Stores applauded the introduction of S. 557, the Medication Therapy Management Empowerment Act of 2013, introduced yesterday by U.S. Sens. Kay Hagan, D-N.C., and Pat Roberts, R-Kan., along with the support of original cosponsors U.S. Sens. Sherrod Brown, D-Ohio, Al Franken, D-Minn., Tim Johnson, D-S.D., and Amy Klobuchar, D-Minn.

WASHINGTON — The National Association of Chain Drug Stores (NACDS) today applauded the introduction of S. 557, the Medication Therapy Management Empowerment Act of 2013, introduced yesterday by U.S. Sens. Kay Hagan, D-N.C., and Pat Roberts, R-Kan., along with the support of original cosponsors U.S. Sens. Sherrod Brown, D-Ohio, Al Franken, D-Minn., Tim Johnson, D-S.D., and Amy Klobuchar, D-Minn. The legislation seeks to expand access to MTM services for senior citizens enrolled in the Medicare program.

March 15, 2013

The National Community Pharmacists Association endorsed H.R. 1188, legislation introduced by U.S. Reps. Tom Marino, R-Pa., and Judy Chu, D-Calif., that would allow independent community pharmacies to collectively negotiate.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Friday endorsed H.R. 1188, legislation introduced by U.S. Reps. Tom Marino, R-Pa., and Judy Chu, D-Calif. The bill will allow independent community pharmacies to collectively negotiate the terms and conditions of insurance contracts they must sign, typically with pharmacy benefit managers that administer prescription drug plans. 

March 15, 2013

U.S. Senators Pat Roberts, R-Kan., and Kay Hagan, D-N.C., introduced legislation written to lower healthcare costs by helping more seniors better manage their prescriptions.

WASHINGTON — U.S. Senators Pat Roberts, R-Kan. and Kay Hagan, D-N.C. on Thursday introduced legislation written to lower healthcare costs by helping more seniors better manage their prescriptions. The Medication Therapy Management Empowerment Act will allow seniors with any high-cost chronic illness to review all their medication and develop a plan of action with a pharmacist.

March 14, 2013

A plan to significantly reduce generic drug prices in Alberta has drawn criticism from pharmacists in the Canadian province.

EDMONTON, Alberta — A plan to significantly reduce generic drug prices in Alberta has drawn criticism from pharmacists in the Canadian province.

The Alberta Pharmacists' Association said it was "shocked" in response to the provincial government's 2013 budget, which reduces generic drug prices from 35% to 18% of branded drug prices, effective May 1. Over the past two years, prices have been reduced from 75% to 35%, but the RxA said it supported the government in those cases.

March 14, 2013

The Food and Drug Administration has approved a drug for obsessive compulsive disorder made by Par Pharmaceutical Cos., the drug maker said Thursday.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a drug for obsessive compulsive disorder made by Par Pharmaceutical Cos., the drug maker said Thursday.

Par announced the approval and shipment of fluvoxamine maleate extended-release capsules in the 100-mg and 150-mg strengths. The drug is a generic version of Jazz Pharmaceuticals' Luvox CR.

March 14, 2013

The Food and Drug Administration will decide in late August whether to approve an experimental opioid painkiller made by QRxPharma, the drug maker said Thursday.

BEDMINSTER, N.J. — The Food and Drug Administration will decide in late August whether to approve an experimental opioid painkiller made by QRxPharma, the drug maker said Thursday.

Australia-based QRxPharma is seeking approval for Moxduo (morphine and oxycodone), and the FDA plans to decide whether to approve the drug on Aug. 26.

March 14, 2013

Amid a tide of automatic spending cuts resulting from the failure of Congress and the White House to agree on a budget, the generic drug lobby has offered some suggestions to generate savings.

WASHINGTON — Amid a tide of automatic spending cuts resulting from the failure of Congress and the White House to agree on a budget, the generic drug lobby has offered some suggestions to generate savings.

March 14, 2013

Missouri attorney general Chris Koster joined Jackson County prosecutor Jean Peters Baker and leaders from the Missouri Pharmacy Association and the Jackson County Sheriff’s Office to launch the state’s new voluntary retail Anti-Smurfing Campaign.

KANSAS CITY, Mo. — Missouri attorney general Chris Koster joined Jackson County prosecutor Jean Peters Baker and leaders from the Missouri Pharmacy Association and the Jackson County Sheriff’s Office on Wednesday to launch the state’s new voluntary retail Anti-Smurfing Campaign.

March 14, 2013

Mylan has settled a patent-infringement lawsuit filed by Shionogi over its generic version of a drug for diabetes, Mylan said.

PITTSBURGH — Mylan has settled a patent-infringement lawsuit filed by Shionogi over its generic version of a drug for diabetes, Mylan said.

The generic drug maker said that under the agreement, it can launch a generic version of Shionogi's Fortamet (metformin hydrochloride) extended-release tablets in the 500-mg and 1,000-mg strengths on Aug. 1.

Metformin hydrochloride extended-release tablets in those two strengths had sales of about $125 million during the 12-month period that ended in September, according to IMS Health.

 

March 14, 2013

The director of the Food and Drug Administration's Office of Generic Drugs is stepping down, according to published reports.

NEW YORK — The director of the Food and Drug Administration's Office of Generic Drugs is stepping down, according to published reports.

Pharmalot, a blog run by journalist Ed Silverman, reported that Greg Geba is leaving the office over differences resulting from a recent reorganization, effective Friday.

March 14, 2013

Walgreens was singled out in a lawsuit earlier this week for suggesting a vitamin E supplement may help improve cardiovascular health.

BAKERSFIELD, Calif. — Walgreens was singled out in a lawsuit earlier this week here for suggesting a vitamin E supplement may help improve cardiovascular health. 

Specifically, according to a Reuters report Monday, the complainant stated that Walgreens' Vitamin E 400 IU purported to "naturally contribute to cardiovascular health by helping to protect LDL cholesterol from oxidation which may cause cellular damage." 

March 13, 2013

Actress Meryl Streep will encourage people to get screened for colorectal cancer in a new series of public service announcements from the Entertainment Industry Foundation's National Colorectal Cancer Research Alliance and the Centers for Disease Control and Prevention, the groups said Wednesday.

LOS ANGELES — Actress Meryl Streep will encourage people to get screened for colorectal cancer in a new series of public service announcements from the Entertainment Industry Foundation's National Colorectal Cancer Research Alliance and the Centers for Disease Control and Prevention, the groups said Wednesday.

March 13, 2013

Bills introduced in Oregon's state legislature would allow employers and other health plan sponsors to have greater knowledge about how pharmacy benefit managers determine the rates at which they pay pharmacies for dispensing generic drugs; establish new standards for pharmacy audits while requiring PBMs to register in the state and be licensed by the state board of pharmacy; and prevent health plans from requiring residents of the state to use mail-order pharmacies.

NEW YORK — Bills introduced in Oregon's state legislature would allow employers and other health plan sponsors to have greater knowledge about how pharmacy benefit managers determine the rates at which they pay pharmacies for dispensing generic drugs; establish new standards for pharmacy audits while requiring PBMs to register in the state and be licensed by the state board of pharmacy; and prevent health plans from requiring residents of the state to use mail-order pharmacies.

March 13, 2013

The improvement in cardiovascular health that results from quitting smoking far outweighs the limited risks to cardiovascular health from the modest amount of weight gained after quitting, according to a National Institutes of Health-funded community study.

BETHESDA, Md. — The improvement in cardiovascular health that results from quitting smoking far outweighs the limited risks to cardiovascular health from the modest amount of weight gained after quitting, according to a National Institutes of Health-funded community study released Wednesday. 

March 13, 2013

Retail sales for the month of February rose by 1.1% seasonally adjusted month to month, according to figures released Wednesday by the Department of Commerce.

WASHINGTON — Retail sales for the month of February rose by 1.1% seasonally adjusted month to month, according to figures released Wednesday by the Department of Commerce.

The newly released figures include nongeneral merchandise categories, such as automobiles, gas stations and restaurants; excluding those, sales rose 0.7%, while rising 0.5% unadjusted year over year. The National Retail Federation noted that sales beat estimates as consumers adapted and adjusted spending in response to higher gas prices and the payroll tax increase.

March 12, 2013

Actavis is challenging Novartis' patent on a patch used to treat Alzheimer's disease, Actavis said.

PARSIPPANY, N.J. — Actavis is challenging Novartis' patent on a patch used to treat Alzheimer's disease, Actavis said.

The generic drug maker said it had filed with the Food and Drug Administration an amendment to its regulatory application for rivastigmine transdermal system to include the 13.3 mg-per-24-hours dosage strength, a generic version of Novartis' Exelon. Novartis filed suit against Actavis on Thursday in the U.S. District Court for the District of Delaware seeking to prevent commercialization of the generic version.

March 12, 2013

The Consumer Healthcare Products Association's Annual Executive Conference was sold out for the first time since 2001, CHPA president and CEO Scott Melville told a packed morning session, and that is a strong prognosticator as to the health and vitality of the self-care industry.

NAPLES, Fla. — The Consumer Healthcare Products Association's Annual Executive Conference was sold out for the first time since 2001, CHPA president and CEO Scott Melville told a packed morning session, and that is a strong prognosticator as to the health and vitality of the self-care industry.