Archive for the 'North America News' Category
Shortages 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 »
Endo 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 »
Recent 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 »
In 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 »
Efforts 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 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.
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.
The recent presidential and vice-presidential debates have highlighted the need for strategies for economic growth in the US, including the roles innovation and trade play in stimulating the US economy. Eli Lilly Chairman, President and CEO John C. Lechleiter recently weighed in on the issue with respect to the pharmaceutical industry in offering his perspective on the importance of including data exclusivity provisions for biologics as found in US law for the Trans-Pacific Partnership (TPP), a regional free trade pact in Asia under negotiation.
In an op-ed in the New York Times, a trio of physicians from the Memorial Sloan Kettering Cancer Center in New York announced their decision to remove an expensive new cancer treatment from the hospital formulary, citing cost-benefit as their reason. The physicians said that because Zaltrap (ziv-aflibercept) made by Sanofi/Regeneron was no better at extending median survival in advanced metastatic bowel cancer patients than Avastin (bevacizumab) from Roche/Genentech but costs more than twice as much, it would no longer be given to patients at the hospital. Read more »