Archive for the 'North America News' Category

Spot Shortages and New Approvals for US Influenza Vaccine

Recently, after reading about the severity of this year’s flu season, I finally went and got my vaccine, which my doctor had been out of when I tried in October. I received one of the last doses the clinic had on hand, and two other places I called were already out. Apparently, others in the US have been experiencing similar situations. FDA Commissioner Margaret Hamburg posted Jan. 14 on the FDA blog that vaccines are available but FDA is monitoring spot shortages. Read more »

FDA’s Position on Abuse-Deterrant Opioid Formulations Becomes Clearer

Amy RitterWith the release of a draft guidance on the evaluation and labeling of abuse-deterrent opioid formulations, FDA is one step closer to clarifying its thinking on acceptable formulations for this product class. Read more »

Pharma 2012 Layoffs

Purchaser of Unapproved Drugs Pleads Guilty

Amy RitterShortages of certain sterile injectables pushed some practices to source these products from unapproved distributers. Back in February 2012, counterfeit versions of Roche/Genentech’s cancer drug, Avastin, appeared in the US, prompting FDA to send letters to practices that had purchased drugs from several foreign distributers, including Clinical Care, Quality Specialty Products (QSP), Montana Health Care Solutions, and Bridgewater Medical. Read more »

Opioid Formulation: Out with the Old

Amy RitterEndo Pharmaceuticals, maker of the opioid medication Opana ER (oxymorphone HCl), is suing FDA to prevent generic manufacturers from entering the market with formulations of oxymorphone that are not abuse-resistant. Read more »

Pharma Gains from Rule On Health Insurance Benefits

Jill Wechsler Washington EditorRecent change likely to boost drug coverage by plans, but with variation in formularies.

Health plans offering coverage to individuals and small companies are more likely to cover multiple drugs in each class or category under revised regulations proposed by the Department of Health and Human Services in November. A key change in rules to implement the Affordable Care Act (ACA) is regarded as a big win for pharma, as some 20 million Americans are expected to enroll in plans sold through exchanges, greatly expanding the market for prescription drugs. Read more »

Will FDA Gain More Oversight Over Compounders?

Amy RitterIn the wake of the meningitis outbreak caused by contaminated compounded medications produced by the New England Compounding Center (NECC), both the government and the public have been wrestling with the question of how this happened—how did a company producing substandard medicines slip through regulatory oversight? Read more »

Key Healthcare Challenges for Obama, Congress

Jill Wechsler Washington EditorEfforts to repeal the Affordable Care Act (ACA) died on election day, as President Barack Obama won a second term in the White House and the Democrats maintained control of the Senate. House Republicans will continue to challenge various provisions in the health care legislation, but key provisions for pharmaceutical companies, such as rebates on drugs for seniors in the Part D coverage gap and authorization for biosimilars, are unlikely to change. Read more »

FDA Assesses Goals due to Hurricane Sandy

FDA has pushed back goals in relation to the Prescription Drug User Fee Act (PDUFA), the Biosimilar User Fee Act (BsUFA), and Medical Device User Fee Act (MDUFA) as a result of the closing of agency offices during Hurricane Sandy. FDA says it will assess the goals that were due October 31 and extend them as needed. The extensions will be no more than the number of business days the agency was closed.

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Purdue Pharma Issues Grant to NASCSA to Combat Abuse and Diversion of Prescription Medications

The prescription drug-abuse problem in the US has grown to epidemic proportions in recent years. According to MedlinePlus, a service of the US National Library of Medicine, an estimated 20% of people in this country have used prescription drugs for nonmedical reasons. The National Institute on Drug Abuse (NIDA) cites a 2011 University of Michigan study that prescription drugs such as Vicodin (acetaminophen; hydrocodone bitartrate), Adderall (amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate), and cough medicine are abused more among seniors in high school than illicit drugs such as MDMA, hallucinogens, and cocaine.

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