Content about Pharmaceuticals policy

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

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 8, 2013

Medication-information website Drugs.com has launched a mobile app that includes access to personal medication records, drug-interaction lists and breaking health news, the company said Friday.

NEW YORK — Medication-information website Drugs.com has launched a mobile app that includes access to personal medication records, drug-interaction lists and breaking health news, the company said Friday.

The Drugs.com Medication Guide is available free of charge for iOS and Android phones and includes tools such as MedNotes, the Symptom Checker and an A-to-Z index of more than 24,000 prescription and OTC drugs, including information about whether drugs are available as generics.

March 8, 2013

Republican and Democratic senators have re-introduced legislation that would ban patent settlements between branded and generic drug companies that critics allege violate antitrust laws, according to published reports.

WASHINGTON — Republican and Democratic senators have re-introduced legislation that would ban patent settlements between branded and generic drug companies that critics allege violate antitrust laws, according to published reports.

March 8, 2013

Just about every healthcare practitioner recommends over-the-counter medicines to their patients. And nearly 3-out-of-4 make that OTC recommendation as the first therapy option, according to a recent survey released by the Consumer Healthcare Products Association.

This is another proof point that OTC medicines play an important role in holding down cost.

Just about every healthcare practitioner recommends over-the-counter medicines to their patients. And nearly 3-out-of-4 make that OTC recommendation as the first therapy option, according to a recent survey released by the Consumer Healthcare Products Association. 

This is another proof point that OTC medicines play an important role in holding down cost. 

March 6, 2013

Acura Pharmaceuticals announced that its next-generation pseudoephedrine with abuse-deterrent technology will now be stocked by North Carolina's Kerr Drug.

PALATINE, Ill. — Acura Pharmaceuticals on Tuesday announced that its next-generation pseudoephedrine with abuse-deterrent technology will now be stocked by North Carolina's Kerr Drug. 

Nexafed is a 30 mg immediate-release pseudoephedrine product that combines effective nasal-congestion relief with a unique technology that disrupts the conversion of pseudoephedrine into methamphetamine, Acura noted. 

March 6, 2013

Prescription-only pseudoephedrine laws result in well more than $278 million in additional burdens to taxpayers, according to a study published by Matrix Global Advisors.

WASHINGTON — Prescription-only pseudoephedrine laws result in well more than $278 million in additional burdens to taxpayers, according to a study published by Matrix Global Advisors on Monday. 

March 6, 2013

Nearly 98% of primary care physicians, nurse practitioners and pharmacists trust and recommend over-the-counter medicines to their patients, according to a new survey released Wednesday by the Consumer Healthcare Products Association.

WASHINGTON — Nearly 98% of primary care physicians, nurse practitioners and pharmacists trust and recommend over-the-counter medicines to their patients, according to a new survey released Wednesday by the Consumer Healthcare Products Association. Nearly three-fourths of primary care physicians recommend OTC medicines to relieve symptoms before recommending a prescription treatment.

March 5, 2013

The stakes are high in a case involving generic drug maker Actavis and the Federal Trade Commission that will soon go before the Supreme Court, the head of a generic drug industry lobbying group said in a conference call with reporters Tuesday.

NEW YORK — The stakes are high in a case involving generic drug maker Actavis and the Federal Trade Commission that will soon go before the Supreme Court, the head of a generic drug industry lobbying group said in a conference call with reporters Tuesday.

The case, FTC v. Actavis, will go before the high court on March 25 and may decide the future of patent settlements between branded and generic drug companies. The Generic Pharmaceutical Association filed an amicus brief with the court last week defending the settlements as beneficial to consumers.

March 4, 2013

The National Community Pharmacists Association submitted written comments urging the Centers for Medicare and Medicaid Services to take action on a wide range of what NCPA characterizes as "anti-patient, anti-pharmacist practices," the association announced.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Friday submitted written comments urging the Centers for Medicare and Medicaid Services to take action on a wide range of what NCPA characterizes as "anti-patient, anti-pharmacist practices," the association announced. 

March 1, 2013

The Consumer Healthcare Products Association on Friday released a statement regarding a poll released last week by the Asthma and Allergy Foundation of America.

WASHINGTON — The Consumer Healthcare Products Association on Friday released a statement regarding a poll released last week by the Asthma and Allergy Foundation of America. 

March 1, 2013

The Supreme Court will hear arguments later this month in a case that could determine the future of many patent settlements between brand and generic drug makers.

WASHINGTON — The Supreme Court will hear arguments later this month in a case that could determine the future of many patent settlements between brand and generic drug makers.

The high court will hear arguments in the case, Federal Trade Commission v. Actavis, on March 25. The case was originally titled FTC v. Watson, but has changed since Watson Pharmaceuticals changed its name following its acquisition of Swiss generic drug maker Actavis.

February 28, 2013

The battle over "pay for delay" continues to heat up, and its resolution likely won't come until the nation's highest court decides on the legality of the practice.

The battle over "pay for delay" continues to heat up, and its resolution likely won't come until the nation's highest court decides on the legality of the practice.

February 28, 2013

Canadian generic drug makers expressed dismay over a new plan to reduce reimbursements for a half-dozen generic medications in most of the country's provinces. According to published reports, a group of premiers had reached a coordinated deal to reduce the prices their governments paid for six generic drugs, hoping to save the provinces nearly $100 million.

Canadian generic drug makers expressed dismay over a new plan to reduce reimbursements for a half-dozen generic medications in most of the country's provinces. According to published reports, a group of premiers had reached a coordinated deal to reduce the prices their governments paid for six generic drugs, hoping to save the provinces nearly $100 million.

February 28, 2013

Alabama's Supreme Court ruled in January that brand-name drug companies could be sued if patients suffer complications from generic versions of their medicines, according to published reports.

Alabama's Supreme Court ruled in January that brand-name drug companies could be sued if patients suffer complications from generic versions of their medicines, according to published reports. According to the New York Times, an Alabama man named Danny Weeks claimed he developed tardive dyskinesia after taking generic versions of Pfizer's acid reflux drug Reglan (metoclopramide). Pfizer acquired rights to the drug when it bought Wyeth in 2009, and generic drug makers Teva and Actavis, now owned by Watson, make generic versions.

February 28, 2013

The Food and Drug Administration has set user fee rates for generic drug companies, the agency said Jan. 27.

SILVER SPRING, Md. — The Food and Drug Administration has set user fee rates for generic drug companies, the agency said Jan. 27.

The FDA announced that it had published a notice in the Federal Register for companies that make finished dosage forms, meaning drugs in their final form, and active pharmaceutical ingredients, meaning the main ingredients of the drugs.

February 28, 2013

It's been long accepted that politics makes strange bedfellows. That's certainly the case with the reauthorization in 2012 of the Prescription Drug User Fee Act.

It's been long accepted that politics makes strange bedfellows. That's certainly the case with the reauthorization in 2012 of the Prescription Drug User Fee Act.

Leaders in both the branded and generic drug industries praised the reauthorization last June of PDUFA, the 20-year-old system by which research-based pharmaceutical companies help fund the government's expensive review and testing process for new drug applications.

February 28, 2013

Has the explosion in generic utilization curbed pioneer-drug research and development? That's one concern floated by some pharmaceutical industry watchers, who claim that the stunning market share gains made by generic drug makers could reduce incentives for branded drug companies to spend to develop new molecular entities, conduct lengthy clinical trials, gain FDA approval and bring those new drugs to market.

Has the explosion in generic utilization curbed pioneer-drug research and development? That's one concern floated by some pharmaceutical industry watchers, who claim that the stunning market share gains made by generic drug makers could reduce incentives for branded drug companies to spend to develop new molecular entities, conduct lengthy clinical trials, gain FDA approval and bring those new drugs to market.

February 28, 2013

The world market for generic drugs will jump more than 15% this year and reach a global total of $127.8 billion, predicted a report from British market research firm Visiongain.

Generics expected to hit double-digit growth

February 28, 2013

Biosimilar medicines have been approved and routinely prescribed in Europe for nearly seven years, and creation of a clear pathway for Food and Drug Administration review and approval of generic versions of bioengineered drugs was enshrined into law in the United States with the passage of the Patient Protection and Affordable Care Act nearly three years ago.

Biosimilar medicines have been approved and routinely prescribed in Europe for nearly seven years, and creation of a clear pathway for Food and Drug Administration review and approval of generic versions of bioengineered drugs was enshrined into law in the United States with the passage of the Patient Protection and Affordable Care Act nearly three years ago. But IMS Health and other industry experts agree it could still be years before biosimilars are available to pharmacies and patients in this country.

February 28, 2013

Pharmacy benefit managers are becoming increasingly adept at leveraging the power of generics to save client healthcare dollars and improve their own standing, reports indicated.

Pharmacy benefit managers are becoming increasingly adept at leveraging the power of generics to save client healthcare dollars and improve their own standing, reports indicated.

"The opportunity for lowering costs by promoting generics over brands has never been greater, given the unprecedented number of drugs set to lose patent protection over the next few years," noted the "2012 Towers Watson/National Business Group on Health Employer Survey on Purchasing Value in Health Care."

February 28, 2013

Are doctors needlessly raising the costs of America's healthcare system through their prescribing habits? Absolutely, say researchers.

Are doctors needlessly raising the costs of America's healthcare system through their prescribing habits? Absolutely, say researchers. A new report appearing in the Jan. 7 issue of JAMA Internal Medicine highlighted the powerful role played by branded drug advertising on consumer preferences and physicians' prescribing habits, and asserted that many doctors ignore the cost-saving benefits of generic drugs when writing prescriptions by acceding to patients' wishes.

February 26, 2013

A newly conducted study of millions of Medicare Part D prescription drug event data has found that community pharmacies provide 90-day medication supplies at lower cost than mail-order pharmacies and that local pharmacists substitute lower-cost generic drugs more often when compared with mail-order pharmacies.

ALEXANDRIA, Va. — A newly conducted study of millions of Medicare Part D prescription drug event data has found that community pharmacies provide 90-day medication supplies at lower cost than mail-order pharmacies and that local pharmacists substitute lower-cost generic drugs more often when compared with mail-order pharmacies.

February 25, 2013

The generic drug tidal wave became a tsunami in 2012, with some of the world's top-selling pharmaceuticals swamped by generic competition, and health plan payers scrambling to reap billions of dollars in financial savings.

The generic drug tidal wave became a tsunami in 2012, with some of the world's top-selling pharmaceuticals swamped by generic competition, and health plan payers scrambling to reap billions of dollars in financial savings.

February 22, 2013

One of the FDA's chief duties is ensuring the quality of food and drug products, and that was the focus of a keynote address delivered at the GPhA annual meeting.

NEW YORK — One of the Food and Drug Administration's chief duties is ensuring the quality of food and drug products, and that was the focus of a keynote address delivered Friday morning by FDA commissioner Margaret Hamburg at the Generic Pharmaceutical Association's annual meeting.

In the address, viewed via webcast, Hamburg addressed issues ranging from quality to drug shortages to follow-on biologics, praising the generics industry's role in contributing more than $1 trillion in savings to the healthcare system over the past decade.