Category:

A Texas judge invalidated Allergan patents on its dry eye medicine Restasis on the grounds that the patents cover obvious ideas...Judge William Bryson issued the ruling in federal court in Marshall, Texas, in a longstanding dispute between Allergan and generic drugmakers led by Mylan NV and Teva Pharmaceutical Industries Ltd...The ruling could enable the generic drug companies to sell their own versions of Restasis, which generated around $1.5 billion in sales for Allergan last year and accounted for more than 10 percent of the company's revenue...Allergan's stock price dropped about 5 percent on the news...The patents at issue were the same ones Allergan transferred to a Native American tribe in an effort to protect them from administrative review...

Chicago has moved a step closer to placing major restrictions on pharmacist workloads in a bid to improve consumer safety...The City Council Finance Committee on Tuesday approved a measure that would allow Chicago pharmacists to fill prescription orders for no more than 10 patients per hour, as well as guaranteeing meal and washroom breaks. It also would require pharmacies to post a list in plain sight showing which pharmacists and technicians have worked shifts longer than eight hours...The proposal's sponsor, Ald. Edward Burke, the committee's chairman, said he hoped to bring the plan up for a vote in the full City Council...The...alderman has argued that the proposal would reduce the "undue levels of stress" on pharmacists caused by pressure from retailers to fill hundreds of prescriptions a day. Pharmacists working constantly for as long as 12 hours a day have said they worry about losing focus during busy shifts and potentially putting their customers in jeopardy...Along with the 10-patient-per-hour limit, Burke's Chicago proposal would give pharmacists who work at least seven hours in a shift two 15-minute breaks and one 30-minute meal break. A pharmacy also would need to schedule at least 10 pharmacy technician hours per 100 prescriptions filled.

California governor Jerry Brown has just signed SB-17 – Drug Price Transparency into state law...This law is truly nutty. It won’t accomplish much of what it purports to do...Pharmacies and healthcare providers will become the primary beneficiaries of SB17’s requirement that pharmaceutical manufacturers provide advance notice of WAC price increases. Payers and patients will see limited gains. The state of California will see no appreciable benefit...This unexpected result will occur because the revenues and profits of pharmacies are linked directly to brand-name list prices. By providing advance notice of a price increases, pharmacies will have enormous incentives to purchase extra inventory and earn windfall profits. These profits do not have to be shared with third-party payers or patients...SB17 should encourage manufacturers to begin exploring direct inventory management relationships with key pharmacies to minimize speculation and the accompanying risks of drug shortages and diversion. It will be tough to negotiate these agreements, because pharmacies will see the lure of big profits...speculative purchasing will wreak havoc with pharmaceutical supply chains. What were California’s legislators thinking? Do they have any idea how little California will benefit from advance notice? What will happen to the excess inventory and higher pharmacy profits generated by California’s new law?...Don’t ask the people who wrote the bill. They seem completely oblivious to SB17’s actual impact...

Nearly every day for at least two decades pharmaceutical drugs have been brought by the carload to the Capitol — an arrangement so under the radar that even pharmacy lobbyists who regularly pitch Congress on their industry aren’t aware of it...The deliveries arrive at the secretive Office of the Attending Physician, an elaborate medical clinic where Navy doctors triage medical emergencies and provide basic health care for lawmakers who pay an annual fee of just over $600. Every one comes from Washington’s oldest community pharmacy, Grubb’s...Mike Kim...pharmacist-turned-owner of the pharmacy, said he has gotten used to knowing the most sensitive details about some of the most famous people in Washington...“At first it’s cool, and then you realize, I’m filling some drugs that are for some pretty serious health problems as well. And these are the people that are running the country,” Kim said, listing treatments for conditions like diabetes and Alzheimer’s...Kim’s tiny pharmacy — which, at its busiest, sends as many as 100 prescriptions to members in a day — is nestled among Capitol Hill’s stateliest row houses, less than four blocks from the Capitol building itself. Founded in 1867 and named for a previous owner, the pharmacy predates penicillin, the American health insurance system, and even the Lincoln Memorial.

J&J won the reversal of a verdict in favor of the family of a woman whose death...stemmed from her use of the company's talc-based products...J&J, which won one Missouri trial, says it faces lawsuits by 4,800 plaintiffs nationally asserting similar claims over its talc-based products...It also faces cases in California, where in August a jury awarded a woman $417 million...Johnson & Johnson...won the reversal of a $72 million verdict in favor of the family of a woman whose death from ovarian cancer they claimed stemmed from her use of the company's talc-based products like Johnson's Baby Powder...The Missouri Court of Appeals for the Eastern District said that given a recent U.S. Supreme Court decision that limited where injury lawsuits could be filed, the case over Alabama resident Jacqueline Fox's death should not have been tried in St. Louis.

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

Gov. Jerry Brown signed California's AB-265, which will limit the use of copay coupons and other discounting strategies for branded prescription drugs when a cheaper generic is available. Brown authorized that bill on the same day he signed SB-17, a separate piece of legislation which will force drugmakers to give warning of and explain price hikes...Exceptions to the copay coupon law include cases in which patients complete step therapy or receive prior authorization for the branded drug...the bills represent two significant regulatory steps on drug pricing...they are a setback for the drug industry in California. But other states could follow the model as many around the country look to take pharmaceutical prices into their own hands...PhRMA,...opposed both proposals...concerned with AB-265 because it doesn't ensure that patients who need a branded med over a generic will be able to get that drug...When patients receive short-term co-pay assistance for expensive drugs, they may be insulated from price hikes, but insurance companies, the government and employers still bear the burden of these excessive prices...these costs are eventually passed on to consumers in the form of higher premiums...

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

While restrictions are increasing, a third of plans impose none...Medicare plans place few restrictions on the coverage of prescription opioids, despite federal guidelines recommending such restrictions, a new Yale study finds. The research results highlight an untapped opportunity for Medicare formularies to limit opioid prescribing... little is known about opioid coverage and restrictions under Medicare, which often serves as the standard for other insurers...Prescribing restrictions can have an impact...A prior study of a private insurer reported a 15% decrease in opioid prescribing when the insurer implemented restrictions, including prior authorization, quantity limits, and provider–patient agreements...

China has said it will accept data from clinical trials run overseas in a bid to shorten the time it takes to approve new drugs and medical devices...It’s the latest in a string of regulatory initiatives implemented by Chinese authorities that could be a boost for international biopharma companies as well as Chinese patients, who sometimes have to wait six or seven years after launch in Western markets for drugs to be launched in China...The country’s huge and increasingly affluent population is facing an ever-growing burden of chronic diseases like cancer and diabetes, and the government has been under pressure to improve access to healthcare and new medicines...The latest wide-ranging set of proposals...recognizes that China is lagging behind other countries when it comes to approving new drugs. It’s approved 100 innovative new drugs in the last five years, around a third the number in developed markets...