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Generic drug prices in Medicare Part D decreased significantly in recent years, a new report from the U.S. Government Accountability Office says. So why the worry about price hikes? Hundreds of products saw “extraordinary price increases," that's why...For a group of 2,378 generic drugs--including those that entered or exited the market from 2010 to 2015--Medicare Part D prices fell overall by 59%...But “established generics"--the 1,441 drugs that stayed on the market the entire time--fell by just 22%. More than 300 cases of “extraordinary price increases” kept prices from falling further...Those extraordinary hikes amounted to at least 100%…The Generic Pharmaceutical Association is praising the newest GAO report. “At a time when everyone is looking for cost saving solutions, it is important to note that the GAO findings are consistent with the prevailing market trend--generic drug prices overall continue to decline year over year,”…

An Ohio court has given a significant boost to a controversial ballot measure that is designed to lower the cost of medicines...In a ruling...the state Supreme Court decided that thousands of contested signatures on petitions submitted to the General Assembly were valid...The 4-to-3 decision capped months of procedural and legal skirmishes over the Ohio Drug Price Relief Act, which would require the state to pay no more for medicines than the US Department of Veterans Affairs...the ballot measure was opposed by the Pharmaceutical Research and Manufacturers of America...the Ohio Manufacturers Association, and the Ohio Chamber of Commerce. The groups contested the validity of signatures on a petition that had to be submitted to the general assembly as part of the state’s two-step process to place a measure on the ballot...Some statewide organizations and health care experts are concerned that the proposal, if enacted, is unworkable and will force a lengthy and complex litigation and bureaucratic quagmire...

A major food allergy advocacy group said this week that it would stop accepting donations immediately from drug companies selling epinephrine auto-injectors until there is “meaningful competition” in the market...While not mentioning Mylan by name, the statement from Food Allergy Research and Education implies that the EpiPen manufacturer is one of the targets. Mylan is the only one of FARE’s corporate sponsors that currently markets epinephrine auto-injectors. The organization...would not specify the exact amount of money that Mylan has donated to FARE, and the statement did not address how it would make up the lost donations...The organization has been actively involved in efforts across the country to expand access to epinephrine auto-injectors in public places like schools...

Shares of Kroger were lower Wednesday. The supermarket chain has emerged as a buyer for stores of Rite Aid. The drugstore chain is close to being acquired by Walgreens Boots Alliance, but Rite Aid would have to sell off overlapping assets in order to appease regulators. Kroger looks to be the potential buyer for all of Rite-Aid's overlapping stores considering that it is well capitalized and has experience running pharmacies in its stores.

The partners will develop a comprehensive diabetes platform and combine software, devices, medicine and professional care to improve diabetes management for patients...Verily Life Sciences, a subsidiary of Google’s parent company, Alphabet and Sanofi, a French multinational pharmaceutical company launched Onduo - a joint venture to improve diabetes care...The collaboration will leverage Verily’s miniaturized electronics, analytics and consumer software with Sanofi’s clinical expertise to create innovative treatments for diabetes patients…Onduo is designed to...help people with diabetes live full, healthy lives by developing comprehensive solutions that combine devices, software, medicine and professional care to enable simple and intelligent disease management...

Pfizer Inc's trial data on Chantix, a drug to help people quit smoking, failed to impress U.S. Food and Drug Administration scientists, in a blow to the company's attempts to have a serious warning removed from the drug's label...The FDA...expressed concerns about the collection and interpretation of data from a post-marketing study on the controversial drug...Pfizer has been trying to have the "black box" warning - which warns of psychiatric risks including suicidal thoughts, hostility and agitation - removed from the drug's label...the study...compared Chantix or...Zyban with a placebo or a nicotine patch in smokers with and without a history of psychiatric disorders, showed that the drug did not significantly increase the incidence of serious neuropsychiatric side-effects...FDA staff disputed the results, flagging inconsistencies in data collection and characterization of the severity of some side-effects...

The way we pay for prescription drugs is more complex than the way we pay for anything else in the health system...When we pay for innovative medications...we’re not paying just for the pill – we’re paying a high price to incentivize the 10 years of clinical research needed to get that drug through the FDA approval process, and all the failures along the way. This high price is often negotiated down by various middlemen, but it nevertheless remains a "monopoly price." Patents, along with FDA-granted market exclusivity, preclude competitors from marketing the same drug under the same or different name for a period of time...the U.S. doesn’t have any national, price controls, profit controls, or other active or passive forms of across-the-board price regulation. This makes the American drug market unique, both in its strengths and weaknesses. Drug pricing reform should ideally protect those strengths while minimizing the weaknesses...

Grandma as a menacing wolf. Parents whose carelessness leads to cancer in their kids. A teenager hospitalized after sharing a seemingly innocent kiss. Halloween may still be over a month away, but Big Pharma is already out to scare consumers...In recent months, several fear-instilling, often ominous commercials for medical devices, products and vaccines from drugmakers including Pfizer, GlaxoSmithKline and Mylan are airing in fairly heavy rotation…If you increase an individual's feeling that they're susceptible to a threat, and increase the perceived severity of that threat, people are more likely to take action...a trend with companies, especially ones with injectable drugs and vaccines, which also have big price increases, is to scare people into buying their product or getting their vaccine...Fear can be motivating until it's demotivating...There's a threshold at which we turn off and say, 'That's not me, that's someone else—my brain can't handle this level of risk and information.'...

A European Commission court upheld an antitrust fine that was imposed three years ago against Lundbeck and four other drug makers for allegedly conspiring to delay the availability of a lower-cost generic version of an antidepressant...The ruling...came in response to an appeal of a 2013 decision that found Lundbeck and the generic drug makers pursued a pay-to-delay deal that violated European Union anticompetition regulations. The European Commission had fined the companies a total of $165 million with Lundbeck ordered to pay the bulk of the fine, or about $105 million...Regulators argue these deals are anticompetitive, force consumers to overpay for medicines, and escalate costs to the overall health care system. In the United States, the Federal Trade Commission estimates such deals cost Americans about $3.5 billion annually. Drug makers counter that the deals are not only legal, but allow lower-cost generic drugs to reach consumers faster than if patent litigation continued...

The FDA’s Office of Criminal Investigations has spent thousands of hours pursuing foreign-imported, mislabeled drugs. But more than half of all OCI cases end without charges, and critics contend the agency’s efforts protect drug makers as much as consumers...On April 5, 2012, a criminal investigator from the Food and Drug Administration named Robert West charged into an oncology clinic...West was chasing a lead that Dr. Anindya Sen...purchased an unapproved...cancer drug Avastin...Without a warrant or permission, he and an FBI agent rifled through cabinets, seizing drugs that appeared to have foreign, non-FDA approved packaging…A...judge later said West’s...statement about the drugs being counterfeit "apparently was not the truth." West’s search was declared illegal, and the evidence was deemed inadmissible…Prosecutors are declining to pursue many FDA cases, citing a lack of prosecutorial merit, criminal intent or strong evidence, Reuters found in a review of more than 170 letters detailing why the Department of Justice declined cases. The letters, obtained under the Freedom of Information Act, appear to bolster critics’ claims of agency overreaching…