Category:

A team of JAMA authors urged the FDA in 2014 to add "black box" warnings to dopamine agonists, linking the Parkinson's meds to pathological gambling, compulsive shopping and sexual obsessions...Public Citizen is upping the ante with a citizen petition to the agency, citing more than 80 studies supporting its claims...Public Citizen’s petition calls for stronger warnings on six FDA-approved medicines including GlaxoSmithKline’s Requip, Boehringer Ingelheim’s Mirapex and UCB’s Neupro. Used to treat Parkinson’s disease and restless leg syndrome, the medicines can cause uncontrollable urges that in turn lead patients to divorce, financial ruin and suicide attempts…

National Institutes of Health...rejected a request by several consumer groups to override the patent on a prostate cancer drug because the medicine is more expensive in the United States than elsewhere...(consumer) groups petitioned the NIH to take this step, which is known as a march-in right, to help US patients because federally funded research was used to create Xtandi (enzalutamide). The drug is sold by Astellas Pharma and has an average wholesale price in the United States of more than $129,000, about two to four times more than what other high-income countries are paying...Under federal law, a march-in right allows an agency that funds private research to require a drug maker to license its patent to another party in order to "alleviate health and safety needs which are not being reasonably satisfied" or when the benefits of a drug are not available on "reasonable terms."...the NIH denied the petition because there was no information to suggest that Xtandi is or will be in short supply...The consumer group plans to submit an appeal...and said it will base its appeal on the NIH’s "flawed legal rationale" about the use of march-in rights and "its lack of analysis concerning its refusal to use a royalty-free license."

Skyrocketing drug prices are forcing states to take unprecedented measures to rein in health care spending. Vermont just became the nation’s first state to require prescription drug pricing transparency. The New York and Massachusetts attorneys general have launched investigations into major pharmaceutical companies’ and insurers’ drug pricing policies and strategies...important steps. But they ignore a key driver of the problem: secondary patents...secondary patents work like this: Companies file for additional, defensive patents to thicken the protection around their original base patents. These additional patents rarely represent anything new in terms of science. Instead, their purpose is to prolong a company’s monopoly and, along with that, its ability to charge high prices for its drugs. Some drugs have dozens of secondary patents...

Pharmaceuticals deals are being reviewed much more often than other mergers at the Federal Trade Commission, according to an analysis...from the FTC...Drug company acquisitions -- vilified as a key driver of price increases that hurt consumers -- were scrutinized twice as frequently as other mergers in 2013 and about four times more in 2014...they were reviewed at roughly three times the rate of other mergers in 2015. Most of the acquisitions ultimately won approval because the agency could assuage concerns with targeted asset sales...Pharmaceuticals is a narrow area with many sub-markets that each have a lot of consumer impact, prompting the frequent reviews. Any two companies are likely to have at least some overlap in an area that requires a more careful look than the boilerplate reporting information provides – including information about drugs in the pipeline that might compete in the near future...pharmaceutical industry has "experienced significant merger activity in recent years" and that the FTC ...continues to carefully review mergers between pharmaceutical manufacturers and require divestitures where necessary to maintain competition...The Commission is committed to enforcing the antitrust laws in pharmaceutical markets to promote competition and prevent conduct that is likely to harm consumer welfare...

A new way to curb the proliferation of prescription painkillers in West Virginia is in the works: "Prescriber report cards."...The state Board of Pharmacy is developing a system that will rank doctors by specialty based on the number of prescriptions they write for pain medications..."We’re going to categorize prescribers, and then send notifications of how they rank among their peers with their prescribing practices," said Michael Goff, a pharmacy board administrator. "It’s a way of telling them, ‘Hey, among other doctors in your field, doctors who do what you do, here’s where you rank.’"...One drawback: The report cards won’t be made public. State law requires such information to be kept confidential. Doctors would only see their own numerical ranking, not a complete list of rankings by specialty...

The latest skirmishes over drug take-back programs yielded a mixed outcome this week for the pharmaceutical industry, which has been battling local governments that want drug makers to pick up the tab...officials in Snohomish County, Wash., voted unanimously to require drug companies to run a program that would allow consumers to dispose of unwanted and unused medicines. At the same, the Los Angeles County Board of Supervisors delayed passing a similar ordinance until November...The actions...underscore the growing challenge that the pharmaceutical industry faces as more local governments consider such programs...Local officials are pursuing these laws in the face of rising disposal costs, growing concerns about contaminants in water supplies, and a desire to reduce the threat of drug abuse stemming from medicines lingering in cabinets...the Pharmaceutical Research and Manufacturers of America...objected to the effort, saying that maintaining the program would be unwieldy and require the added burden of adhering to US Drug Enforcement Administration regulations because controlled substances would likely be turned in by consumers..."Siding with corporate interests over public health and safety can be a dangerous political position, and the people will have the final say," said Heidi Sanborn, the executive director of the California Product Stewardship Council. "This is not over,"....

A congressional committee voted...to make changes to a controversial program that was designed to spur development of new drugs for neglected tropical diseases. But the effort...is still encountering criticism for not going far enough...At issue are priority review vouchers, which can be awarded to a drug maker that wins regulatory approval of a treatment for certain tropical diseases. Companies can later redeem a voucher when seeking approval for yet another medicine that would be used to treat any illness. And the Food and Drug Administration must review the other drug in six months, instead of the standard 10 months...critics say the program does not do enough to ensure drug makers develop needed salves. A chief complaint is that vouchers can be awarded to a company without having to invest in new R&D or even in a new medicine...House Energy and Commerce Committee...voted to address such concerns...For instance, companies would not be awarded a voucher for drugs previously approved in other countries; they would have to provide more information about plans to launch their tropical disease medicines outside the United States; and they would be required to provide data on patient demand worldwide.

Prescription drug addiction, the downward spiral of lives ruined, loved ones lost, and the cost to society were the focus of a daylong meeting convened...by Gov. Brian Sandoval, who called the problem a crisis...Without question this is one of the most important health challenges we currently face...calling prescription drug abuse "one of the deadliest epidemics" in the United States...Statistics are sobering. While overdose deaths related to opiates in Nevada have declined from 517 in 2010 to 382 last year, at least one Nevadan dies every day from an opiate overdose...From 2010 to 2014, hospital inpatient admissions related to opioids jumped to 3,783 from 2,993...Sandoval said he wants the panel to focus on duties and responsibilities of health care licensing boards; coordination among law enforcement; substance abuse treatment; and sale and availability of pharmaceuticals..."We seek answers, not excuses,"...

Colombian Health Minister Alejandro Gaviria has vowed to find a way to force Novartis to lower the price of its Gleevec (imatinib) leukemia treatment. At first, he threatened to sidestep the drug patent to ensure low-cost generic production, but last week he took steps to unilaterally lower the price the government will pay for the medicine...So far, Novartis is not budging. The company argues that any move to jeopardize its patent would distort world trade rules, which, under certain circumstances, permit governments to overlook patents and secure a supply of needed medicines. Moreover, the drug maker notes there are several generic alternatives available to Colombians, so there is no need to haggle over the cost of its cancer medicine...the episode has quickly become an unfortunate litmus test in the struggle over patients and profits...A Novartis spokesman said the company is not threatening litigation against any of the generic companies, but he did not say what steps it might take...the drug maker may have to tough it out and provide Gleevec at a lower price...Novartis refused to give in. Doing so may have defused the crisis, but created a different problem. Drug makers worry that acceding to such demands might create a precedent that would encourage other countries to pursue the same tactic on other drugs. Similar battles have occurred in other countries, notably India, where drug patents have been sidestepped in a few instances...

...the Colombian health minister plans to unilaterally force Novartis to lower the price for its Gleevec (imatinib) cancer medicine after more than two weeks of talks over a price cut went nowhere...In public comments today, Health Minister Alejandro Gaviria said he will declare a lower price for the widely used cancer medicine as being in the public interest because it would save the country needed health dollars. Under this scenario, Novartis would be obligated to sell Gleevec at the new price, although he did not specify what that might be...The battle over Gleevec has been closely watched as the latest manifestation of a global skirmish over the cost of medicines. Patient groups see it as a test case for using legal rights to ensure needed medicines are accessible, while companies see it as a potentially precedent-setting case in which a middle-income country use trade rules to lower its drug costs...