Content about Pharmaceuticals policy

October 14, 2013

The governor of California has vetoed a bill that critics said would have limited patients' access to knock-off versions of biotech drugs.

NEW YORK — The governor of California has vetoed a bill that critics said would have limited patients' access to knock-off versions of biotech drugs.

October 14, 2013

More than three-quarters of Medicare beneficiaries don't compare drug prices when shopping for their health plans, according to a new study.

MOUNTAIN VIEW, Calif. — More than three-quarters of Medicare beneficiaries don't compare drug prices when shopping for their health plans, according to a new study.

The study, conducted by eHealth, found that 78% of respondents don't compare prices, but that the average beneficiary could have saved more than $600 this year on out-of-pocket prescription drug costs if he had. The study was based on an analysis of more than 450,000 unique visitor sessions during Medicare's 2013 Annual Enrollment Period.

October 14, 2013

With this year’s Medicare Annual Election Period overlapping with the unrelated open enrollment for the new federal and state insurance marketplaces, there’s a growing need to help Medicare beneficiaries understand their healthcare coverage options when Medicare open enrollment begins on Oct. 15, Walgreens noted Monday.

DEERFIELD, Ill. — With this year’s Medicare Annual Election Period overlapping with the unrelated open enrollment for the new federal and state insurance marketplaces, there’s a growing need to help Medicare beneficiaries understand their healthcare coverage options when Medicare open enrollment begins on Oct. 15, Walgreens noted Monday. 

October 11, 2013

Auxilium Pharmaceuticals will have exclusive rights to market a drug for erectile dysfunction in the United States and Canada, under a new licensing agreement with the drug's manufacturer.

CHESTERBROOK, Pa. — Auxilium Pharmaceuticals will have exclusive rights to market a drug for erectile dysfunction in the United States and Canada, under a new licensing agreement with the drug's manufacturer.

October 11, 2013

A new law in Maine will allow the importation of drugs from abroad through mail-order from some pharmacies, formalizing a practice that has existed in many parts of the country for several years, and marking the first time a state government has, by law, gone against Food and Drug Administration regulations that bar importation of drugs.

Bloomberg columnist Megan McArdle said Maine was "going rogue" on drug importation, and that pretty much sums it up. The state, which has long had a close relationship with Canada — its governor, Paul LePage, is of French-Canadian descent and spoke Quebecois French as his first language — is openly defying federal law. And because federal law ultimately trumps state law, it's likely the federal government will crack down at some point.

A new law in Maine will allow the importation of drugs from abroad through mail-order from some pharmacies, formalizing a practice that has existed in many parts of the country for several years, and marking the first time a state government has, by law, gone against Food and Drug Administration regulations that bar importation of drugs.

October 10, 2013

One of the Food and Drug Administration's top regulators is not retiring, contrary to rumors reported in news media Thursday.

SILVER SPRING, Md. – One of the Food and Drug Administration's top regulators is not retiring, contrary to rumors reported in news media Thursday.

In a memo sent out to staff, Center for Drug Evaluation and Research director Janet Woodcock wrote that she would not retire, but was becoming "more deeply involved" in such activities as proposed reorganizations of the Office of Pharmaceutical Quality and the Office of Generic Drugs.

October 10, 2013

For the Food and Drug Administration’s Office of Generic Drugs, one of the biggest stumbling blocks has been its significant backlog of generic drug approval applications. But it’s steadily making progress in addressing the problem.

For the Food and Drug Administration’s Office of Generic Drugs, one of the biggest stumbling blocks has been its significant backlog of generic drug approval applications. But it’s steadily making progress in addressing the problem.

When Congress approved a reauthorization of the Prescription Drug User Fee Act that included the Generic Drug User Fee Amendments last year, that backlog included about 2,500 applications. But thanks to GDUFA, the agency has managed to clear muchof it.

October 10, 2013

A coalition of organizations that includes major retail pharmacy and drug manufacturing groups is warning consumers against purchasing drug from foreign, online outlets.

NEW YORK — A coalition of organizations that includes major retail pharmacy and drug manufacturing groups is warning consumers against purchasing drugs from foreign, online outlets.

October 10, 2013

While the boom in generic drugs now looks set to wane, another segment of the pharmaceutical industry is rapidly rising and presenting new growth opportunities for pharmacy retailers: specialty drugs.

While the boom in generic drugs now looks set to wane, another segment of the pharmaceutical industry is rapidly rising and presenting new growth opportunities for pharmacy retailers: specialty drugs.

October 8, 2013

Consumers in the United States are more likely than those in three other countries to say they prefer to receive generic drugs over branded drugs, according to a new study.

RHINEBECK, N.Y. — Consumers in the United States are more likely than those in three other countries to say they prefer to receive generic drugs over branded drugs, according to a new study.

The study, by Phoenix Marketing International, included 810 consumers from the United States, Canada, the United Kingdom and France. Among respondents, 37% of American consumers expressed a preference for generics when they were available, compared with 22% of those in France, 12% in the United Kingdom and 21% in Canada.

October 8, 2013

GreenLight Rx is offering a line of medicine bottles aimed at elderly people and those suffering from such conditions as arthritis, the company said.

SANTA ANA, Calif. — GreenLight Rx is offering a line of medicine bottles aimed at elderly people and those suffering from such conditions as arthritis, the company said.

October 7, 2013

An analysis by the New York Times published over the weekend makes the case for generic drugs.

NEW YORK — An analysis by the New York Times published over the weekend makes the case for generic drugs.

Times reporter Katie Thomas opened the analysis Saturday by recalling an episode of the Netflix series "Orange Is the New Black," in which the prison saves money by switching inmates to generic drugs, much to their dismay. But that bit of artistic license on the part of the show's writers is evidence of the negative perceptions of generic drugs among the public.

October 7, 2013

Doctors have continued prescribing antibiotics for mild conditions that don't require them despite decades of efforts by government authorities to discourage the practice, according to a new study.

NEW YORK — Doctors have continued prescribing antibiotics for mild conditions that don't require them despite decades of efforts by government authorities to discourage the practice, according to a new study.

October 7, 2013

Next year, the share of brand-name drugs paid by Medicare Part D beneficiaries will drop to 47.5%. The share of generics will drop to 72%, according to a report published Monday in the Wall Street Journal.

NEW YORK — Next year, the share of brand-name drugs paid by Medicare Part D beneficiaries will drop to 47.5%. The share of generics will drop to 72%, according to a report published Monday in The Wall Street Journal.

October 3, 2013

A patient may be able to eat all of the ice cream he wants after having his tonsils removed, but researchers at Henry Ford Hospital in Detroit say he doesn't necessarily need a prescription to reduce post-operative pain — an over-the-counter pain reliever is just as effective.

DETROIT — A patient may be able to eat all of the ice cream he wants after having his tonsils removed, but researchers at Henry Ford Hospital in Detroit say he doesn't necessarily need a prescription to reduce post-operative pain — an over-the-counter pain reliever is just as effective.

The study released Monday found over-the-counter ibuprofen manages pain after a tonsillectomy for children and adults, as well as the prescription pain medications acetaminophen with hydrocodone and acetaminophen with codeine, which is no longer recommended for use in children.

October 1, 2013

The message in October is "Know Your Pharmacist, Know Your Medicine" as the American Pharmacists Association launches its annual American Pharmacists Month.

WASHINGTON — The message in October is "Know Your Pharmacist, Know Your Medicine" as the American Pharmacists Association launches its annual American Pharmacists Month.

October 1, 2013

Rite Aid will help elderly people and their caregivers prepare for the annual Medicare Part D enrollment starting in two weeks, the drug store chain said Tuesday.

CAMP HILL, Pa. — Rite Aid will help elderly people and their caregivers prepare for the annual Medicare Part D enrollment starting in two weeks, the drug store chain said Tuesday.

Rite Aid said its stores around the country would offer Medicare Advisor to help Medicare beneficiaries and caregivers find the plan that suits them best starting on Oct. 15.

October 1, 2013

Health insurer WellPoint said Tuesday that most of its affiliated Medicare drug plans and medical plans with drug coverage will participate in a preferred pharmacy network that includes Rite Aid, Kroger and Walmart pharmacies.

INDIANAPOLIS — Health insurer WellPoint said Tuesday that most of its affiliated Medicare drug plans and medical plans with drug coverage will participate in a preferred pharmacy network that includes Rite Aid, Kroger and Walmart pharmacies.

Together, WellPoint said, members had access to more than 11,000 locations around the country. The preferred pharmacy network is part of all of WellPoint's affiliated Part D standalone prescription drug plans and most of its Medicare Advantage Prescription Drug Plans.

September 30, 2013

Amneal Pharmaceuticals has bought rights to four generic drugs from Actavis, Amneal said Monday.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has bought rights to four generic drugs from Actavis, Amneal said Monday.

September 30, 2013

The National Criminal Justice Association has recognized a program to combat prescription drug abuse in Arizona as the best such program in the west of the country.

MOUNT PROSPECT, Ill. — The National Criminal Justice Association has recognized a program to combat prescription drug abuse in Arizona as the best such program in the west of the country.

The National Association of Boards of Pharmacy said the Arizona Prescription Drug Misuse and Abuse Initiative received the NCJA's 2013 Western Region Outstanding Criminal Justice Program Award. The program involves state agencies and organizations, including the Arizona State Board of Pharmacy.

September 27, 2013

A bill designed to strengthen the security of the drug supply chain by creating an electronic track-and-trace system and national standards for sterile pharmacy compounding has attracted support from trade groups representing independent pharmacies and generic drug makers.

WASHINGTON — A bill designed to strengthen the security of the drug supply chain by creating an electronic track-and-trace system and national standards for sterile pharmacy compounding has attracted support from trade groups representing retail pharmacies and generic drug makers.

September 25, 2013

The board of directors of the World Self-Medication Industry on Wednesday named as its chair-elect Erica Mann, member of the Bayer HealthCare executive committee and president of Bayer HealthCare’s Global Consumer Care division.

LEVERKUSEN, Germany — The board of directors of the World Self-Medication Industry on Wednesday named as its chair-elect Erica Mann, member of the Bayer HealthCare executive committee and president of Bayer HealthCare’s Global Consumer Care division. Mann will succeed current chair Zhenyu Guo, CEO, Dihon Pharmaceutical at the completion of his term in June 2014.

September 23, 2013

The Food and Drug Administration will not enforce regulatory requirements for most mobile medical apps because they "post minimal risk to consumers," the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration will not enforce regulatory requirements for most mobile medical apps because they "post minimal risk to consumers," the agency said Monday.

The FDA announced the issuance of guidance on the apps, saying it would adopt a "tailored policy" toward regulation, focusing its regulatory oversight on those apps that present greater risk if they do not work as intended.

September 23, 2013

Sandoz has launched an authorized generic drug for treating a disease commonly known as pre-leukemia, the company said on Monday.

PRINCETON, N.J. — Sandoz has launched an authorized generic drug for treating a disease commonly known as pre-leukemia, the company said on Monday.

September 20, 2013

Perrigo Co. has hired a former Food and Drug Administration official for its regulatory department, the drug maker said.

ALLEGAN, Mich. — Perrigo Co. has hired a former Food and Drug Administration official for its regulatory department, the drug maker said Friday.

The Allegan, Mich.-based drug maker announced the appointment of Keith Webber as head of regulatory review, a position in which he will start on Oct. 21. Webber previously served as acting director of the FDA's Office of Pharmaceutical Science, part of the Center for Drug Evaluation and Research, which regulates prescription and OTC drugs. He also served as director of the Office of Generic Drugs.