Content about Regulatory and Washington

February 13, 2012

The flu season is in full swing as California reported widespread influenza activity, according to data reported by state and territorial epidemiologists and published by the Centers for Disease Control and Prevention.

ATLANTA — The flu season is in full swing as California reported widespread influenza activity, according to data reported by state and territorial epidemiologists and published by the Centers for Disease Control and Prevention.

February 13, 2012

The Obama administration will not make any additional changes to its rule that will mandate health insurance plans to provide free contraception to women, despite reports of a compromise with those that were against the requirement.

WASHINGTON — The Obama administration will not make any additional changes to its rule that will mandate health insurance plans to provide free contraception to women, despite reports of a compromise with those that were against the requirement.

February 13, 2012

A subsidiary of Watson Pharmaceuticals is seeking approval for its version of an oral contraceptive from the Food and Drug Administration.

PARSIPPANY, N.J. — A subsidiary of Watson Pharmaceuticals is seeking approval for its version of an oral contraceptive from the Food and Drug Administration.

Watson Labs has filed an abbreviated new drug application with the FDA and is seeing to market drospirenone and ethinyl estradiol and levomefolate calcium tablets in the 3-mg/0.02-mg/0.451-mg strength and levomefolate calcium tablets in the 0.451-mg strength, a generic version of Bayer HealthCare Pharmaceuticals' Beyaz.

February 10, 2012

An expert panel at the Food and Drug Administration has given a thumbs-down to a drug made by Astex Pharmaceuticals and Eisai for which the two had sought approval as a treatment for leukemia.

DUBLIN, Calif. — An expert panel at the Food and Drug Administration has given a thumbs-down to a drug made by Astex Pharmaceuticals and Eisai for which the two had sought approval as a treatment for leukemia.

The FDA's Oncologic Drugs Advisory Committee voted 10-3 with one abstention not to support the risk-benefit profile of Dacogen (decitabine) in certain elderly patients with acute myeloid leukemia. The FDA is not bound by advisory committee votes when deciding whether or not to approve a drug, but usually follows them.

February 10, 2012

Bloomberg on Friday reported that Express Scripts intends to inform the Federal Trade Commission that the company has delivered all the data requested regarding its purchase of Medco Health Solutions on Friday, which will trigger a 30-day period for a decision from the FTC.

NEW YORK — Bloomberg on Friday reported that Express Scripts intends to inform the Federal Trade Commission that the company has delivered all the data requested regarding its purchase of Medco Health Solutions on Friday, which will trigger a 30-day period for a decision from the FTC.

Express Scripts declined to comment for the story, Bloomberg added.

February 10, 2012

Controversy over a plan by the Obama administration to require health insurance plans to provide free contraception to women has led the administration to seek a policy that it is calling a compromise with conservative groups opposed to the measure, according to published reports.

NEW YORK — Controversy over a plan by the Obama administration to require health insurance plans to provide free contraception to women has led the administration to seek a policy that it is calling a compromise with conservative groups opposed to the measure, according to published reports.

The controversy surrounded the new rule's requirement that employee health insurance plans provide free birth control, including those run by the Roman Catholic church, such as hospitals and universities. The Church opposes birth control.

February 9, 2012

The Center for Reproductive Rights on Wednesday asked a federal court to reopen its 2005 lawsuit against the Food and Drug Administration for imposing age restrictions on emergency contraceptive drugs.

NEW YORK — The Center for Reproductive Rights on Wednesday asked a federal court to reopen its 2005 lawsuit against the Food and Drug Administration for imposing age restrictions on emergency contraceptive drugs. Presently, emergency contraceptives, like Plan B One Step, are available behind a pharmacy counter for women 17 years and older but require a prescription for women under the age of 17 years.

February 9, 2012

The Food and Drug Administration has approved an antimicrobial drug made by Mylan, the drug maker said Thursday.

PITTSBURGH — The Food and Drug Administration has approved an antimicrobial drug made by Mylan, the drug maker said Thursday.

The FDA approved Mylan's doxycycline hyalite delayed-release tablets in the 150-mg strength. The drug is a generic version of Warner Chilcott's Doryx.

February 9, 2012

The Food and Drug Administration on Wednesday issued a public warning that the use of proton-pump inhibitors or H2 blockers may be associated with an increased risk of Clostridium difficile–associated diarrhea, or CDAD.

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday issued a public warning that the use of proton-pump inhibitors or H2 blockers may be associated with an increased risk of Clostridium difficile–associated diarrhea, or CDAD.

Patients should immediately contact their healthcare professional and seek care if they take PPIs and develop diarrhea that does not improve, the agency stated.

February 9, 2012

The Food and Drug Administration reached a major milestone on the path to a regulatory regime for follow-on biologics on Thursday with the release of draft guidance on biosimilar product development.

SILVER SPRING, Md. — The Food and Drug Administration reached a major milestone on the path to a regulatory regime for follow-on biologics on Thursday with the release of draft guidance on biosimilar product development.

February 9, 2012

The generic drug industry's main lobby is hoping Congress will act on a proposed user fee program for generic drugs that it helped negotiate with the Food and Drug Administration.

WASHINGTON — The generic drug industry's main lobby is hoping Congress will act on a proposed user fee program for generic drugs that it helped negotiate with the Food and Drug Administration.

February 8, 2012

The amount of trans fats found in blood levels of U.S. white adults has significantly dropped over a nine-year period, according to a study conducted by the Centers for Disease Control and Prevention.

ATLANTA — The amount of trans fats found in blood levels of U.S. white adults has significantly dropped over a nine-year period, according to a study conducted by the Centers for Disease Control and Prevention.

February 8, 2012

While the financial burden that families face due to prescription drugs has declined, costs nevertheless remain a challenge for many of them, according to a new study by nonprofit research organization Rand Corp.

NEW YORK — While the financial burden that families face due to prescription drugs has declined, costs nevertheless remain a challenge for many of them, according to a new study by nonprofit research organization Rand Corp.

February 8, 2012

The Food and Drug Administration has approved a head lice treatment made by Sanofi, the drug maker said.

BRIDGEWATER, N.J. — The Food and Drug Administration has approved a head lice treatment made by Sanofi, the drug maker said.

Sanofi announced the approval of Sklice (ivermectin) lotion in the 0.5% strength for patients ages 6 months and older. According to Sanofi, head lice infest an estimated 6 to 12 million children ages 3 to 11 years and costs as much as $1 billion in lost school days and lost work for parents.

February 7, 2012

The Food and Drug Administration has approved a drug made by Shire for attention deficit hyperactivity disorder, the company said Tuesday.

PHILADELPHIA — The Food and Drug Administration has approved a drug made by Shire for attention deficit hyperactivity disorder, the company said Tuesday.

Shire announced the FDA approval of Vyvanse (lisdexamfetamine dimesylate) capsules as a maintenance treatment for adults with ADHD. The drug already was approved for use in children and was approved for treating ADHD in adults in 2008.

The company said the approval was based on a clinical trial that showed more ADHD patients controlling their symptoms with Vyvanse than with placebo.

February 7, 2012

Cardinal Health was granted a temporary restraining order Friday against the Drug Enforcement Administration's suspension order of its Lakeland, Fla., distribution center.

DUBLIN, Ohio — Cardinal Health was granted a temporary restraining order Friday against the Drug Enforcement Administration's suspension order of its Lakeland, Fla., distribution center.

A preliminary injunction hearing is currently scheduled for Feb. 13.

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.