Content about Regulatory and Washington

March 16, 2012

Another generic drug maker has joined efforts to challenge the patent on a drug made by Forest Labs for treating hypertension.

NEW YORK — Another generic drug maker has joined efforts to challenge the patent on a drug made by Forest Labs for treating hypertension.

March 16, 2012

The National Association of Chain Drug Stores is praising lawmakers in Medco Health Solutions’ home state of New Jersey for delivering what NACDS called “a bold and revealing blow” to the PBM’s proposed merger with Express Scripts.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores is praising lawmakers in Medco Health Solutions’ home state of New Jersey for delivering what NACDS called “a bold and revealing blow” to the PBM’s proposed merger with Express Scripts.

March 15, 2012

The Food and Drug Administration has approved a drug that the manufacturer called the first oral contraceptive that also treats heavy menstrual bleeding.

WAYNE, N.J. — The Food and Drug Administration has approved a drug that the manufacturer called the first oral contraceptive that also treats heavy menstrual bleeding.

Bayer HealthCare Pharmaceuticals announced Wednesday the approval of Natazia (estradiol valerate and estradiol valerate and dienogest) tablets for heavy menstrual bleeding not caused by any conditions of the uterus. The drug was originally approved as an oral contraceptive in May 2010.

March 15, 2012

The Food and Drug Administration approved an effervescent tablet for treating osteoporosis.

FREIENBACH, Switzerland — The Food and Drug Administration approved an effervescent tablet for treating osteoporosis.

EffRx Pharmaceuticals announced the FDA approval of Binosto (alendronate sodium), a strawberry-flavored tablet designed to dissolve in water that the company called the first treatment of its kind. The drug is designed to treat osteoporosis in menopausal women and increase bone mass in men with osteoporosis. EffRx expects to launch Binosto in third quarter 2012.

March 14, 2012

Endo Pharmaceuticals is hoping the Food and Drug Administration will back tougher regulatory approval requirements for generic versions of one of its drugs.

CHADDS FORD, Pa. — Endo Pharmaceuticals is hoping the Food and Drug Administration will back tougher regulatory approval requirements for generic versions of one of its drugs.

March 14, 2012

The Food and Drug Administration has approved the first generic version of an antidepressant made by Forest Labs, the agency said Wednesday.

SILVER SPRINGS, Md. — The Food and Drug Administration has approved the first generic version of an antidepressant made by Forest Labs, the agency said Wednesday.

The FDA announced the approval of a generic version of Lexapro (escitalopram) made by Teva Pharmaceutical Industries in the 5-mg, 10-mg and 20-mg strengths. The drug is used to treat depression and generalized anxiety disorder in adults.

March 14, 2012

Forest Labs has filed suit against Glenmark Generics and several other companies, alleging that they infringed on its patent for a drug to treat hypertension by seeking regulatory approval for generic versions.

NEW YORK — Forest Labs has filed suit against Glenmark Generics and several other companies, alleging that they infringed on its patent for a drug to treat hypertension by seeking regulatory approval for generic versions.

Forest and Johnson & Johnson subsidiary Janssen Pharmaceutica NV have sued Glenmark, Hetero USA, Torrent Pharmaceuticals and Watson Labs in response to their filing regulatory approval applications with the Food and Drug Administration for generic versions of Bystolic (nebivolol).

March 14, 2012

Legislation designed to reform the pharmacy audit process has been approved in Utah and will be sent to the state governor to sign.

ALEXANDRIA, Va. — Legislation designed to reform the pharmacy audit process has been approved in Utah and will be sent to the state governor to sign.

In a 73-1 vote, H.B. 76, known as the Pharmacy Audit Integrity and Recovery Act, "requires health benefit plans, the Public Employees' Benefits and Insurance Program and pharmacy benefit managers to implement certain pharmacy audit procedures when auditing pharmacy claims," according to the legislation document. Key provisions included:

March 13, 2012

One-third or more of rogue online pharmacy domains are under one Internet registrar, with two registrars accounting for more than half, according to a new report.

NEW YORK — One-third or more of rogue online pharmacy domains are under one Internet registrar, with two registrars accounting for more than half, according to a new report.

March 13, 2012

The National Association of Chain Drug Stores is heading to Capitol Hill next week for its RxImpact Day event, during which it will press its case against the proposed ESI-Medco merger.

WASHINGTON — The National Association of Chain Drug Stores is heading to Capitol Hill next week for its RxImpact Day event, during which it will press its case against the proposed ESI-Medco merger.

“No issues are higher on NACDS’ list of priorities than urging members of Congress to express to the Federal Trade Commission their concerns and opposition to the proposed Express Scripts and Medco merger, and advocating for legislation to regulate pharmacy benefit managers,” stated NACDS president and CEO Steve Anderson.

March 13, 2012

West Virginia has become the 19th state to require pharmacists and other retailers to be connected through the National Precursor Log Exchange system with the passage of legislation that requires real-time, stop-sale technology to enable the state's pharmacists to block illegal pseudoephedrine purchases right at the point of sale and provide law enforcement with up-to-the minute criminal data.

WASHINGTON — West Virginia has become the 19th state to require pharmacists and other retailers to be connected through the National Precursor Log Exchange system with the passage of legislation that requires real-time, stop-sale technology to enable the state's pharmacists to block illegal pseudoephedrine purchases right at the point of sale and provide law enforcement with up-to-the minute criminal data.

March 12, 2012

One of pharmacy's top awards is getting some support from a German drug maker. Boehringer Ingelheim announced that it became a premier supporter of the American Pharmacists Association's Bowl of Hygeia Award.

RIDGEFIELD, Conn. — One of pharmacy's top awards is getting some support from a German drug maker. Boehringer Ingelheim announced that it became a premier supporter of the American Pharmacists Association's Bowl of Hygeia Award.

March 9, 2012

A new partnership aims to educate pharmacists, other healthcare professionals, caregivers and patients about diabetes and about how pharmacists can work with physicians to help patients manage the condition.

WASHINGTON — A new partnership aims to educate pharmacists, other healthcare professionals, caregivers and patients about diabetes and about how pharmacists can work with physicians to help patients manage the condition.

The American Pharmacists Association, the APhA Foundation and the American Diabetes Association announced the collaboration Friday, saying it would develop new resources and also promote existing programs, such as the ADA's Stop Diabetes Movement and the APhA's Pharmaceutical Care for Patients with Diabetes certification program.

March 9, 2012

The Food and Drug Administration has approved a version of a drug made by Teva that includes a dose counter, the drug maker said.

NORTH WALES, Pa. — The Food and Drug Administration has approved a version of a drug made by Teva that includes a dose counter, the drug maker said.

Teva announced the approval of the inhaled drug ProAir HFA (albuterol sulfate) with a dose counter for treating bronchospasm with reversible obstructive airway disease and preventing exercise-induced bronchospasm in patients ages 4 years and older. The dose counter is designed to help patients and caregivers keep track of the number of doses in the canister.

March 9, 2012

A Food and Drug Administration panel will meet Monday to discuss a class of drugs designed to treat chronic painful conditions that currently are under development and the safety issues possibly related to the drugs.

WASHINGTON — A Food and Drug Administration panel will meet Monday to discuss a class of drugs designed to treat chronic painful conditions that currently are under development and the safety issues possibly related to the drugs.

March 9, 2012

The National Association of Chain Drug Stores on Friday applauded the Senate for passage of the Counterfeit Drug Penalty Enhancement Act (S. 1886), which NACDS said would protect the health and safety of consumers by increasing penalties on criminals that engage in the harmful practice of trafficking in counterfeit medications.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores on Friday applauded the Senate for passage of the Counterfeit Drug Penalty Enhancement Act (S. 1886), which NACDS said would protect the health and safety of consumers by increasing penalties on criminals that engage in the harmful practice of trafficking in counterfeit medications.

The bill is sponsored by Sens. Patrick Leahy, D-Vt., Charles Grassley, R-Iowa, and Michael Bennet, D-Colo.



March 9, 2012

The U.S. surgeon general this week released a report on tobacco use among the nation's youth.

WASHINGTON — The U.S. surgeon general this week released a report on tobacco use among the nation's youth.

March 8, 2012

A Consumer Healthcare Products Association study earlier this year supported what everyone has known all along: Use of over-the-counter medicines saves the U.S. healthcare system money. A lot of it. 


WASHINgTON — A Consumer Healthcare Products Association study earlier this year supported what everyone has known all along: Use of over-the-counter medicines saves the U.S. healthcare system money. A lot of it. 


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, according to CHPA’s study, “The Value of OTC Medicine to the United States.”


March 8, 2012

A blood-glucose monitoring system created by Abbott has received clearance from the Food and Drug Administration.

ALAMEDA, Calif. — A blood-glucose monitoring system created by Abbott has received clearance from the Food and Drug Administration.

March 8, 2012

The Food and Drug Administration is looking at the possibility of selling certain prescription drugs over the counter under specific circumstances, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration is looking at the possibility of selling certain prescription drugs over the counter under specific circumstances, the agency said.

March 8, 2012

The number of patients with diabetes is not decreasing any time soon, and one of the most important fronts in the battle lies at the pharmacy counter.


The number of patients with diabetes is not decreasing any time soon, and one of the most important fronts in the battle lies at the pharmacy counter.


March 8, 2012

Written testimony submitted by the National Association of Chain Drug Stores underscored chain pharmacies’ commitment to patient safety as part of the next Prescription Drug User Fee Act reauthorization, and emphasized that community pharmacist-provided services help improve health outcomes without the introduction of unproven technologies.

ALEXANDRIA, Va. — Written testimony submitted by the National Association of Chain Drug Stores underscored chain pharmacies’ commitment to patient safety as part of the next Prescription Drug User Fee Act reauthorization, and emphasized that community pharmacist-provided services help improve health outcomes without the introduction of unproven technologies.

March 7, 2012

Prices for generic drugs may be dropping, but increases in branded and specialty drug prices have offset those decreases, according to a new study.

WASHINGTON — Prices for generic drugs may be dropping, but increases in branded and specialty drug prices have offset those decreases, according to a new study.

The study, conducted by AARP's Public Policy Institute, found that the cumulative change in drug prices from 2005 to 2009 was almost double the rate of inflation. As a result, the average annual cost of drug therapy continued to rise.

March 7, 2012

The maker of a breathable caffeine product has received a warning letter from the Food and Drug Administration.

WASHINGTON — The maker of a breathable caffeine product has received a warning letter from the Food and Drug Administration.

March 7, 2012

The Food and Drug Administration has declined to approve a drug made by Eisai for leukemia in certain elderly patients, the drug maker said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has declined to approve a drug made by Eisai for leukemia in certain elderly patients, the drug maker said.

Eisai said the FDA delivered it a complete response letter for the chemotherapy drug Dacogen (decitabine) in patients ages 65 years and older with acute myeloid leukemia who are not candidates for induction therapy. The FDA delivers a complete response letter when questions remain about an regulatory application that preclude approval, usually due to insufficient clinical trial data.