Content about Regulatory and Washington

April 15, 2014

Actavis on Tuesday announced that it has entered into an agreement with Mylan and Famy Care to settle all outstanding patent litigation related to Mylan's generic version of Generess FE (norethindrone, ethinyl estradiol and ferrous fumarate chewable tablets).

DUBLIN — Actavis on Tuesday announced that it has entered into an agreement with Mylan and Famy Care to settle all outstanding patent litigation related to Mylan's generic version of Generess FE (norethindrone, ethinyl estradiol and ferrous fumarate chewable tablets).

Under the terms of the agreement, Actavis will grant Mylan a license to market its generic version of Generess FE under its pending abbreviated new drug application beginning on April 1, 2015.

April 15, 2014

The Food and Drug Administration on Friday announced a meeting of the Nonprescription Drugs Advisory Committee on May 2 to discuss the potential switch of Merck's Singulair Allergy tablets.

SILVER SPRING, Md. — The Food and Drug Administration on Friday announced a meeting of the Nonprescription Drugs Advisory Committee on May 2 to discuss the potential switch of Merck's Singulair Allergy tablets. 

The proposed OTC use is "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: Nasal congestion, runny nose, itchy, watery eyes, sneezing, itching of the nose.” The applicant proposes to label the product for OTC use in adults 18 years and older. 

April 15, 2014

Prosonix, a speciality pharmaceutical company developing a portfolio of inhaled respiratory medicines by Design, on Tuesday announced that it has entered into a global licensing agreement with Mylan for its leading inhaled respiratory products, PSX1001 and PSX1050.

OXFORD, England  — Prosonix, a speciality pharmaceutical company developing a portfolio of inhaled respiratory medicines by Design, on Tuesday announced that it has entered into a global licensing agreement with Mylan for its leading inhaled respiratory products, PSX1001 and PSX1050.

April 14, 2014

The Biotechnology Industry Organization and the Delaware BioScience Association last week commended the Delaware State Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.

WASHINGTON — The Biotechnology Industry Organization and the Delaware BioScience Association last week commended the Delaware State Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.

The Delaware State Senate passed Senate Substitute 1 for Senate Bill 118. 

April 11, 2014

Now available online, the Drug Enforcement Administration National Prescription Drug Take-Back Day collection site locator allows consumers to search for a nearby location to dispose of unneeded medications on Saturday, April 26, 2014, the National Association of Boards of Pharmacy announced Wednesday.

MOUNT PROSPECT, Ill. — Now available online, the Drug Enforcement Administration National Prescription Drug Take-Back Day collection site locator allows consumers to search for a nearby location to dispose of unneeded medications on Saturday, April 26, 2014, the National Association of Boards of Pharmacy announced Wednesday. On April 26, from 10 a.m.

April 11, 2014

Mylan on Friday confirmed that a federal district court has granted its request to enforce a settlement agreement between Endo Pharmaceuticals and Mylan settling patent litigation in connection with Mylan's filing of an abbreviated new drug application with the Food and Drug Administration for frovatriptan succinate tablets, 2.5 mg.

PITTSBURGH — Mylan on Friday confirmed that a federal district court has granted its request to enforce a settlement agreement between Endo Pharmaceuticals and Mylan settling patent litigation in connection with Mylan's filing of an abbreviated new drug application with the Food and Drug Administration for frovatriptan succinate tablets, 2.5 mg. This product is the generic version of Frova, which is used to treat acute migraine headaches in adults. 

April 11, 2014

NCPDP, the not-for-profit pharmacy standards development organization, on Wednesday announced the availability of a patient safety white paper that provides specific industry guidance for standardizing the dosing designations and labeling of oral liquid medications.

SCOTTSDALE, Ariz. — NCPDP, the not-for-profit pharmacy standards development organization, on Wednesday announced the availability of a patient safety white paper that provides specific industry guidance for standardizing the dosing designations and labeling of oral liquid medications. 

April 11, 2014

The New York State legislature recently wrapped up its 2015 budget negotiations with a favorable outcome for community pharmacy as it rejected an executive branch proposal to change how New York’s Medicaid program reimburses pharmacies for prescription medications.

WASHINGTON — The New York State legislature recently wrapped up its 2015 budget negotiations with a favorable outcome for community pharmacy: It rejected an executive branch proposal to change how New York’s Medicaid program reimburses pharmacies for prescription medications.

If enacted, the proposal would have cut payments to pharmacies by $82 million annually, according to estimates, by setting the price for drugs based on a three-month rolling average acquisition cost.

April 11, 2014

Health and Human Services Secretary Kathleen Sebelius has resigned her post, according to published reports.

WASHINGTON — Health and Human Services Secretary Kathleen Sebelius has resigned her post, according to published reports. 

President Obama accepted the resignation this week and intends to announce that he will nominate Office of Management and Budget Director Sylvia Mathews Burwell to replace Sebelius. A formal announcement is expected Friday, according to reports. 

April 9, 2014

Emphasizing implementation challenges that could impact patient access to pharmacy services, a coalition is urging Secretary of Health and Human Services Secretary Kathleen Sebelius to allow a one-year transition period for states to fully implement the Medicaid average manufacturer’s price-based federal upper limits for prescription medications.

ARLINGTON, Va. — Emphasizing implementation challenges that could impact patient access to pharmacy services, a coalition is urging Secretary of Health and Human Services Secretary Kathleen Sebelius to allow a one-year transition period for states to fully implement the Medicaid average manufacturer’s price-based federal upper limits for prescription medications.

April 9, 2014

The Consumer Healthcare Products Association on Tuesday applauded Tennessee state Rep. Tony Shipley, R-Kingsport, after his legislation — H.B. 1257 — passed out of the Tennessee House of Representatives.

WASHINGTON — The Consumer Healthcare Products Association on Tuesday applauded Tennessee state Rep. Tony Shipley, R-Kingsport, after his legislation — H.B. 1257 — passed out of the Tennessee House of Representatives. The bill, which passed the Senate last week, would implement a real-time, drug offender block list in Tennessee. 

The measure now heads to Tennessee Gov. Bill Haslam for his signature.

April 8, 2014

Healthcare Distribution Management Association president and CEO John Gray on Monday testified before the House Energy and Commerce Subcommittee on Health at a hearing on “Improving Predictability and Transparency in DEA and FDA Regulation.”

ARLINGTON, Va. — Healthcare Distribution Management Association president and CEO John Gray on Monday testified before the House Energy and Commerce Subcommittee on Health at a hearing on “Improving Predictability and Transparency in DEA and FDA Regulation.” HDMA is in support of the Ensuring Patient Access and Effective Drug Enforcement Act of 2014, H.R. 4069, sponsored by Reps. Marino, R-Pa., and Blackburn, R-Tenn. 

April 7, 2014

Mallinckrodt and Questcor Pharmaceuticals on Monday announced that they have entered into a definitive merger agreement under which Mallinckrodt will acquire Questcor in a transaction valued at approximately $5.6 billion.

DUBLIN — Mallinckrodt and Questcor Pharmaceuticals on Monday announced that they have entered into a definitive merger agreement under which Mallinckrodt will acquire Questcor in a transaction valued at approximately $5.6 billion. The transaction was unanimously approved by the boards of directors of both companies. Subject to customary closing conditions, the transaction currently is expected to be completed in the third calendar-quarter of 2014.

April 7, 2014

OncologyRx Care Advantage, McKesson Specialty Health’s oral oncology products specialty pharmacy, on Monday announced that they have assisted under-insured patients in obtaining $40 million in financial assistance by helping them access financial assistance programs.

THE WOODLANDS, Texas — OncologyRx Care Advantage, McKesson Specialty Health’s oral oncology products specialty pharmacy, on Monday announced that they have assisted under-insured patients in obtaining $40 million in financial assistance by helping them access financial assistance programs.

“Without this financial support, most of these patients simply would not be able to obtain the medication they need to continue treatment," said Larry Whisenant, director of Specialty Pharmacy Operations, OncologyRx Care Advantage. 

April 7, 2014

The National Association of Chain Drug Stores submitted a written statement in lead-up to Monday’s hearing of the U.S. House Committee on Energy and Commerce Subcommittee on Health urging transparency in how federal agencies conduct enforcement activities to help curb prescription drug diversion and abuse.

ARLINGTON, Va. — The National Association of Chain Drug Stores submitted a written statement in lead-up to Monday’s hearing of the U.S. House Committee on Energy and Commerce Subcommittee on Health urging transparency in how federal agencies conduct enforcement activities to help curb prescription drug diversion and abuse.

The hearing is titled “Improving Predictability and Transparency in DEA and FDA Regulation.”  

April 7, 2014

Sun Pharma on Sunday announced it will acquire 100% of Ranbaxy in an all-stock transaction valued at $4 billion.

MUMBAI, India — Sun Pharma on Sunday announced it will acquire 100% of Ranbaxy in an all-stock transaction valued at $4 billion. 

The combination of Sun Pharma and Ranbaxy creates the fifth-largest specialty generics company in the world and the largest pharmaceutical company in India, Sun Pharma stated. The combined entity will have operations in 65 countries, 47 manufacturing facilities across five continents, and a significant platform of specialty and generic products marketed globally, including 629 abbreviated new drug applications. 

April 3, 2014

MannKind Corp. on Tuesday announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the Food and Drug Administration voted 13-to-1 to recommend that Afrezza (insulin human [rDNA origin]) inhalation powder be granted marketing approval by the FDA to improve glycemic control in adults with Type 1 diabetes and voted 14-to-0 to recommend that Afrezza be granted marketing approval by the FDA to improve glycemic control in adults with Type 2 diabetes.

VALENCIA, Calif. — MannKind Corp. on Tuesday announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the Food and Drug Administration voted 13-to-1 to recommend that Afrezza (insulin human [rDNA origin]) inhalation powder be granted marketing approval by the FDA to improve glycemic control in adults with Type 1 diabetes and voted 14-to-0 to recommend that Afrezza be granted marketing approval by the FDA to improve glycemic control in adults with Type 2 diabetes. 

March 31, 2014

The Food and Drug Administration on Friday approved Topamax (topiramate) for prevention of migraine headaches in adolescents ages 12 years to 17 years.

SILVER SPRING, Md. — The Food and Drug Administration on Friday approved Topamax (topiramate) for prevention of migraine headaches in adolescents ages 12 years to 17 years. This is the first FDA approval of a drug for migraine prevention in this age group. 

The medication is taken on a daily basis to reduce the frequency of migraine headaches.

Topamax was first approved by the FDA in 1996 to prevent seizures. It was approved for migraine prevention in adults in 2004.

March 31, 2014

The Food and Drug Administration on Friday approved over-the-counter Nexium 24HR (esomeprazole 20mg), Pfizer announced.

NEW YORK — The Food and Drug Administration on Friday approved over-the-counter Nexium 24HR (esomeprazole 20mg), Pfizer announced. 

“Switching medicines, whenever appropriate, from prescription to non-prescription status improves access, empowers consumers to care for their own health and is an important strategy for Pfizer,” stated Paul Sturman, president, Pfizer Consumer Healthcare. “The FDA approval of Nexium 24HR is a significant milestone in executing against our plan.”

March 31, 2014

In an effort to curb abuse of over-the-counter cold and cough medications by minors, Washington Gov. Jay Inslee on Friday signed legislation — House Bill 2163 — that places an age restriction on the purchase of dextromethorphan.

OLYMPIA, Wash. — In an effort to curb abuse of over-the-counter cold and cough medications by minors, Washington Gov. Jay Inslee on Friday signed legislation — House Bill 2163 — that places an age restriction on the purchase of dextromethorphan.

March 28, 2014

According to the National Association of Boards of Pharmacy, a Missouri bill would require health benefit plans to reimburse pharmacies when they dispense less than a 30-day supply for the purpose of synchronizing a patient’s chronic medications.

MOUNT PROSPECT, Ill. — According to the National Association of Boards of Pharmacy, a Missouri bill would require health benefit plans to reimburse pharmacies when they dispense less than a 30-day supply for the purpose of synchronizing a patient’s chronic medications. 

March 28, 2014

Pharmacists in New Mexico have become the first in the United States certified to prescribe Narcan (naloxone), which prevents or reverses the effects of opioids including respiratory depression, sedation and hypotension, according to a report published Wednesday by The New Mexican.

SANTA FE, N.M. — Pharmacists in New Mexico have become the first in the United States certified to prescribe Narcan (naloxone), which prevents or reverses the effects of opioids including respiratory depression, sedation and hypotension, according to a report published Wednesday by The New Mexican

March 28, 2014

More smokers would quit if state Medicaid programs covered more cessation treatments and removed barriers to coverage, according to a Centers for Disease Control and Prevention study published in Thursday's Morbidity and Mortality Weekly Report.

ATLANTA — More smokers would quit if state Medicaid programs covered more cessation treatments and removed barriers to coverage, according to a Centers for Disease Control and Prevention study published in Thursday's Morbidity and Mortality Weekly Report.  

“There’s evidence suggesting that smokers enrolled in Medicaid, like other smokers, want to quit and will take advantage of covered cessation treatments to help them quit for good,” commented Stephen Babb, co-author of the article. 

March 27, 2014

Indiana Governor Mike Pence earlier this week signed legislation designed to create a pathway for the substitution of interchangeable biologic medicines, according to published reports.

INDIANAPOLIS — Indiana Governor Mike Pence earlier this week signed legislation designed to create a pathway for the substitution of interchangeable biologic medicines, according to published reports. 

The bill allows a pharmacist to substitute an interchangeable biosimilar product for a prescribed biological product if certain conditions are met. It requires the board of pharmacy to maintain a website that lists the biosimilar biological products that are determined to be interchangeable. 

The specific conditions include: 

March 27, 2014

The National Association of Chain Drug Stores is urging a Senate Committee to help preserve pharmacy access and choice for Tricare patients, citing in a written statement the importance of advancing policies that control healthcare costs and preserve patient access to the nation’s community pharmacies.

ARLINGTON, Va. — The National Association of Chain Drug Stores is urging a Senate Committee to help preserve pharmacy access and choice for Tricare patients, citing in a written statement the importance of advancing policies that control healthcare costs and preserve patient access to the nation’s community pharmacies.

The subcommittee held a hearing this week titled, “Active, Guard, Reserve and Civilian Personnel Programs.”