Content about Regulatory and Washington

October 28, 2011

Standard monthly premiums under Medicare Part B will be $99.90 in 2012, $6.70 under the projected figure made by the Department of Health and Human Services, HHS announced Thursday.

WASHINGTON — Standard monthly premiums under Medicare Part B will be $99.90 in 2012, $6.70 under the projected figure made by the Department of Health and Human Services, HHS announced Thursday.

This year's Medicare Part B premium is a $15.50 decrease over the standard 2011 premium of $115.40 paid by new enrollees and higher income Medicare beneficiaries and by Medicaid on behalf of low-income enrollees, HHS said. Additionally, the Medicare Part B deductible will be $140, a decrease of $22 from 2011.

October 27, 2011

A company focused on developing niche generic and specialty pharmaceutical products has received regulatory approval from the Food and Drug Administration for its version of a psychiatric drug.

PISCATAWAY, N.J. — A company focused on developing niche generic and specialty pharmaceutical products has received regulatory approval from the Food and Drug Administration for its version of a psychiatric drug.

Innopharma said its abbreviated new drug application for olanzapine injection, a generic equivalent of Zyprexa injection. With this approval, Innopharma announced that it has entered an agreement with Sandoz, who will sell, market and distribute Innopharma's generic in the United States.

October 27, 2011

Mylan has received final approval from the Food and Drug Administration for a drug designed to treat moderate to severe pain.

PITTSBURGH — Mylan has received final approval from the Food and Drug Administration for a drug designed to treat moderate to severe pain.

Mylan said its abbreviated new drug application for morphine sulfate extended-release tablets in the 15-mg, 30-mg, 60-mg, 100-mg and 200-mg strengths was approved by the FDA. The opioid analgesic is a generic version of Purdue Pharma's MS Contin. Mylan said it is launching the product immediately.

Morphine sulfate ER tablets had U.S. sales of approximately $173 million for the 12 months ended in June, according to IMS Health.

October 27, 2011

With the aging population and the rise in the numbers of people with chronic disease states, the country has a huge need for more pharmacists, so what better place is there to look for them than the nation's middle and high schools?

WASHINGTON — With the aging population and the rise in the numbers of people with chronic disease states, the country has a huge need for more pharmacists, so what better place is there to look for them than the nation's middle and high schools?

The American Pharmacists Association and OptumRx announced Thursday the launch of Pharmacy is Right for Me, an educational initiative designed to encourage students in grades 8 through 12 to pursue careers in pharmacy.

October 26, 2011

The Preserve Community Pharmacy Access NOW! coalition, which is a coalition of consumers, businesses and community-based pharmacists from across the country that have come together to oppose the planned mega-merger of Express Scripts and Medco Health Solutions, has issued a call to action to protect Americans from rising costs and decreased access to health care by stopping the planned merger of the PBMs.

WASHINGTON — The Preserve Community Pharmacy Access NOW! coalition, which is a coalition of consumers, businesses and community-based pharmacists from across the country that have come together to oppose the planned mega-merger of Express Scripts and Medco Health Solutions, has issued a call to action to protect Americans from rising costs and decreased access to health care by stopping the planned merger of the PBMs.

October 25, 2011

An advisory committee of the Centers for Disease Control and Prevention is recommending that all boys ages 11 and 12 years old get vaccinated against human papillomavirus, the CDC said Tuesday.

ATLANTA — An advisory committee of the Centers for Disease Control and Prevention is recommending that all boys ages 11 and 12 years old get vaccinated against human papillomavirus, the CDC said Tuesday.

The agency said the Advisory Committee on Immunization Practices voted for recommending routine vaccination of boys with three doses of HPV4 to protect against the virus. The vaccination is able to prevent such HPV-related conditions as cancer and prevent the spread of the virus to sexual partners. The recommendation is still subject to the CDC's approval, the agency said.

October 25, 2011

The Federal Trade Commission released a report Tuesday finding that drug companies entered 28 deals that the FTC called anticompetitive and said would increase healthcare costs for consumers and the government.

WASHINGTON — The Federal Trade Commission released a report Tuesday finding that drug companies entered 28 deals that the FTC called anticompetitive and said would increase healthcare costs for consumers and the government.

The FTC, which under the leadership of chairman Jon Leibowitz, repeatedly has attacked what it calls "pay-for-delay" deals between branded and generic drug manufacturers and has been lobbying the Congressional Joint Select Committee on Deficit Reduction, also known as the super committee, to ban the deals.

October 25, 2011

Lannett has received approval from the Food and Drug Administration to market its version of an anti-obesity drug.

PHILADELPHIA — Lannett has received approval from the Food and Drug Administration to market its version of an anti-obesity drug.

The FDA approved Lannett's abbreviated new drug application for diethylpropion hydrochloride extended-release tablets in the 75-mg strength. The company expects to begin shipping the product immediately.

October 24, 2011

The Food and Drug Administration has approved a new drug for treating a severe form of epilepsy, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a severe form of epilepsy, the agency said Monday.

The FDA announced the approval of Onfi (clobazam) tablets, made by Catalent Pharma Solutions and Lundbeck, as an add-on treatment for seizures associated with Lennox-Gastaut syndrome in patients ages 2 years and older. The agency gave the drug orphan drug designation because the disease affects fewer than 200,000 people in the United States.

October 24, 2011

The Food and Drug Administration has approved the first generic versions of two drugs made by Eli Lilly for treating schizophrenia and bipolar disorder, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved the first generic versions of two drugs made by Eli Lilly for treating schizophrenia and bipolar disorder, the agency said Monday.

The FDA announced the approval of generic olanzapine tablets and olanzapine orally disintegrating tablets, respectively generic versions of Lilly's Zyprexa and Zyprexa Zydus. Dr. Reddy's Labs and Teva Pharmaceuticals USA will manufacture olanzapine tablets, while Dr. Reddy's, Apotex and Par Pharmaceuticals will manufacture the orally disintegrating version.

October 24, 2011

The Food and Drug Administration on Friday issued guidance regarding the use of injector devices to administer flu vaccines to patients.

WASHINGTON — The Food and Drug Administration on Friday issued guidance regarding the use of injector devices to administer flu vaccines to patients.

The FDA said that healthcare professionals should not use such clinical devices to administer flu vaccines, adding that all vaccines, including influenza, "be administered in accordance with their labeling."

October 24, 2011

A number of members of Congress have raised questions about the proposed merger between pharmacy benefit managers Express Scripts and Medco Health Solutions, prompting a lobbying group that represents independent pharmacies and opposes the merger to highlight the matter.

ALEXANDRIA, Va. — A number of members of Congress have raised questions about the proposed merger between pharmacy benefit managers Express Scripts and Medco Health Solutions, prompting a lobbying group that represents independent pharmacies and opposes the merger to highlight the matter.

October 21, 2011

The Food and Drug Administration has approved a new formulation of a testosterone therapy made by Watson Pharmaceuticals, the drug maker said Friday.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a new formulation of a testosterone therapy made by Watson Pharmaceuticals, the drug maker said Friday.

Watson announced the approval of its Androderm (testosterone) transdermal system in the 2-mg and 4-mg formulation. The company said the new smaller size and lower-dose patch would provide "highly effective" testosterone administration with a 20% reduction in the active ingredient from the original strength. Watson plans to launch the new patch next month.

October 21, 2011

General Mills on Thursday announced a voluntary recall of a single day’s production of its chocolate-flavored Fiber One 90-calorie chewy bars because of a labeling issue.

MINNEAPOLIS — General Mills on Thursday announced a voluntary recall of a single day’s production of its chocolate-flavored Fiber One 90-calorie chewy bars because of a labeling issue.

This voluntary recall includes only 5-count boxes of chocolate-flavored Fiber One 90-Calorie chewy bars with the following “better if used by” date printed on the top of the box: "19MAY2012BV."

October 21, 2011

The National Association of Chain Drug Stores submitted on Friday comments to the Centers for Medicare and Medicaid Services regarding the draft federal upper limit list published by CMS.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores submitted on Friday comments to the Centers for Medicare and Medicaid Services regarding the draft federal upper limit list published by CMS.

October 21, 2011

A state pharmacy association here weighed in on the Walgreens and Express Scripts dispute in an editorial published online late Thursday by the Herald Times Reporter.

MANITOWOC, Wis. — A state pharmacy association here weighed in on the Walgreens and Express Scripts dispute in an editorial published online late Thursday by the Herald Times Reporter.

October 21, 2011

Two senators are trying to get the Joint Select Committee on Deficit Reduction to take up a bill that would ban so-called "pay-for-delay" patent settlements between brand and generic drug companies, according to published reports.

WASHINGTON — Two senators are trying to get the Joint Select Committee on Deficit Reduction to take up a bill that would ban so-called "pay-for-delay" patent settlements between brand and generic drug companies, according to published reports.

The Pharma Letter reported that Sens. Herb Kohl, D-Wis., and Chuck Grassley, R-Iowa, had urged the "super committee" to support a bill that would ban settlements that include any form of payment in exchange for holding off launch of a generic drug.

October 20, 2011

A diabetes drug made by Eli Lilly and Amylin Pharmaceuticals has received approval from the Food and Drug Administration for use with an insulin product made by Sanofi.

INDIANAPOLIS — A diabetes drug made by Eli Lilly and Amylin Pharmaceuticals has received approval from the Food and Drug Administration for use with an insulin product made by Sanofi.

Lilly and Amylin said Byetta (eventide) won approval from the FDA as an add-on therapy for patients with Type 2 diabetes taking Sanofi's Lantus (insulin glargine [rDNA origin]) who have not achieved adequate blood sugar control on Lantus alone.

October 20, 2011

A report released by the Institute of Medicine suggested that front-of-package labels don't give clear guidance about a product's healthfulness.

WASHINGTON — A report released by the Institute of Medicine suggested that front-of-package labels don't give clear guidance about a product's healthfulness.

October 20, 2011

Insight Pharmaceuticals is voluntarily recalling one lot of a nasal decongestant due to the possibility of bacterial contamination, the company said.

LANGHORNE, Pa. — Insight Pharmaceuticals is voluntarily recalling one lot of a nasal decongestant due to the possibility of bacterial contamination, the company said.

Insight said it would recall lot number 11G075, UPC code 6373673005, of Nostrilla nasal spray to the consumer level because of possible contamination with Burkholderia cepacia bacteria. The lot, which contains 34,092 bottles, was distributed nationwide to retail outlets.

October 20, 2011

The National Association of Chain Drug Stores has engaged its Rapid Response Program, issuing a letter to the editor to the Los Angeles Times to highlight the importance of maintaining prescription medication access to prevent patient health complications and the increased need for costly forms of health care.

ALEXANDRIA, Va.  — The National Association of Chain Drug Stores has engaged its Rapid Response Program, issuing a letter to the editor to the Los Angeles Times to highlight the importance of maintaining prescription medication access to prevent patient health complications and the increased need for costly forms of health care.

Through the Rapid Response Program, NACDS proactively addresses media reports and other communications in the public domain in a way that raises awareness of the value of community pharmacies as the face of neighborhood healthcare.

October 20, 2011

The Senate voted 55-45 Thursday to scrap an appropriations bill amendment that would have allowed personal importation of prescription drugs.

WASHINGTON — The Senate voted 55-45 Thursday to scrap an appropriations bill amendment that would have allowed personal importation of prescription drugs.

The amendment had been proposed for the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill. The Senate's vote drew applause from an organization representing retail pharmacy chains.

October 20, 2011

Vertex Pharmaceuticals has filed for Food and Drug Administration approval of a drug for cystic fibrosis, the company said.

CAMBRIDGE, Mass. — Vertex Pharmaceuticals has filed for Food and Drug Administration approval of a drug for cystic fibrosis, the company said.

Vertex announced the submission to the FDA of an application for approval and priority review of Kalydeco (ivacaftor), which it said was potentially the first medicine to target the underlying cause of cystic fibrosis, namely mutations in the CFTR gene that causes defective or missing CFTR proteins that inhibit the flow of salt and water across cell membranes and lead to mucus buildup.

October 19, 2011

Concepts in Health on Wednesday reported it successfully has defended its MidNite Sleep Remedy patent from possible infringement by Contract Pharmacal, which had been manufacturing a store-brand version.

BLAUVELT, N.Y. — Concepts in Health on Wednesday reported it successfully has defended its MidNite Sleep Remedy patent from possible infringement by Contract Pharmacal, which had been manufacturing a store-brand version.

According to Concepts, Contract Pharmacal agreed to discontinue manufacturing and selling CVS Natural Sleep Aid or any substantially similar product. Additionally, CPC will not challenge the validity or enforceability of the MidNite patent (U.S. Patent 6,703,412).

October 19, 2011

The Drug Store News Group editor Rob Eder moderated a special Congressional briefing hosted by the American Association of Homeopathic Pharmacists on Sept. 27 for U.S. House of Representatives staffers.


WASHINGTON — The Drug Store News Group editor Rob Eder moderated a special Congressional briefing hosted by the American Association of Homeopathic Pharmacists on Sept. 27 for U.S. House of Representatives staffers.


Eder, who presented on current retail trends in homeopathic remedy sales, Americans’ growing interest in self-care and implications for U.S. health care, also moderated a panel discussion of experts, including AAHP president Mark Land and legal counsel Al Lorman, as well as Wayne Jonas, president and CEO of 
Samueli Institute.