Pharmalot.. Pharmalittle.. As the weekend nears…
October 2, 2015 | Antitrust, Biosimilars, Cancer, FDA, Generics, Painkillers, Uncategorized
By Ed Silverman

And so, another working week will soon draw to a close. You knew this would happen, yes? As you know, this is our treasured signal to daydream about weekend plans. Candidly, we have a rather modest agenda. We hope to catch up on paperwork and reading, indulge the shortest of our short people and take a nap or three. And what about you? This is a fine time of year to enjoy the great outdoors, unless a hurricane is stopping by. In that event, you could tidy up around the castle, reach out to someone special or simply plan the rest of your life. Well, whatever you do, have a grand time. But be safe. See you soon...

Hillary Clinton wants stricter federal regulation of prescription painkillers; Harvard Medical School is reevaluating conflict-of-interest rules amid complaints by some professors the restrictions slow the process of turning discoveries into research tools and treatments; The FDA approved the first therapy combining two cutting-edge cancer agents to treat advanced melanoma; the US Federal Trade Commission argued in a court filing that drug makers that make minor tweaks to their medicines in order to blunt competition from cheaper generics may be violating antitrust laws; and Italy's Guido Rasi will resume leadership of the European Medicines Agency. Read More


U.K. patients want government to override Roche patent on cancer drug
October 1, 2015 | Pricing & Patient Access
By Ed Silverman

A new flare up over prescription drug costs is taking place in the U.K. In a letter to the U.K. Health Secretary a coalition of cancer patients, physicians, and advocacy groups has asked the government to override patents on a Roche breast cancer treatment - and they have already lined up an unnamed drug maker to produce a lower-cost version of the medicine, known as Kadcyla, if the government agrees.

The request comes as patient access to the drug has grown more difficult. Last year, the National Institute for Health and Care Excellence, a government watchdog that measures cost effectiveness of drugs, recommended that Kadcyla not be covered due to the price. The coalition notes the Roche drug, which is known generically as TDM-1, costs about $155,000, or nearly four times the 2014 per capita income of $40,000 in the U.K. Read More


Drug Maker sues Canada for trying to impose a price cap on its medicine
October 1, 2015 | Pricing & Patient Access
By Ed Silverman

The latest skirmish over prescription drug pricing is unfolding in a Canadian court where a government agency and a U.S. drug maker are battling over the cost of an expensive medicine that is used to treat a pair of rare diseases. Last month, Alexion Pharmaceuticals filed a lawsuit to stop the Patented Medicine Prices Review Board, a Canadian government agency, from imposing a price cap on Soliris. The move came after the board last January asked Alexion to lower its price and repay sales generated by the drugs from 2012 through the first half of 2014.

The battle is being closely watched for its wider implications. Beyond disputing specific allegations made by the board, Alexion is taking the unprecedented step of challenging the agency’s power to impose pricing caps. And health policy experts say this development raises questions about the extent to which other drug makers may follow suit. Read More


Drug Makers face probe by New Hampshire over Opioid marketing
October 1, 2015 | FDA, Litigation, Painkillers, Patient Safety
By Ed Silverman

Add New Hampshire to the list of state and local governments confronting drug makers over their marketing of narcotic painkillers. The state’s attorney general, Joseph Foster, is investigating several companies over allegations they minimized the risk that patients could become addicted from long-term use while also exaggerating the benefits for treating chronic pain.

He wants to know whether alleged “fraudulent marketing” misled doctors into writing prescriptions and if state programs then unnecessarily paid for the drugs. Although the investigation is in the early stages, subpoenas have been issued to several drug makers, Read More


Pharmalot.. Pharmalittle.. Good Morning.. Headlines and Coffee are served
October 1, 2015 | FDA, Pricing & Patient Access, Uncategorized
By Ed Silverman

Hello, everyone, and how are you this morning? We are just fine, thank you. Of course, another busy day is unfolding, and so we are coping by quaffing our mandatory cups of stimulation. As always, we invite you to join us. Remember, a prescription is not required. So why not fortify yourselves while you can? You can also enjoy a few items of interest we have assembled for you. Hope you conquer the world today and keep in touch...

Vertex Pharmaceuticals ceo Jeffrey Leiden says that government efforts to rein in prescription drug prices could stymie the development of innovative medicines; Express Scripts, the largest pharmacy benefits manager in the U.S., says two costly new cholesterol treatments - the PCSK-9 inhibitors - will not be budget busters; A fight over how long to protect biologics from lower-cost imitators is now the leading obstacle to negotiations aimed at completing a 12-nation trade agreement spanning the Pacific; and Sarepta Therapeutics released new data on its Duchenne muscular dystrophy drug the company believes make a strong case supporting U.S. approval early next year. Read More


What risk? Physician group questions FDA view on Testosterone drugs
September 30, 2015 | FDA, Uncategorized
By Ed Silverman

A leading physicians group is questioning claims that testosterone replacement therapy increases the risk of heart disease - contradicting concerns expressed by the Food and Drug Administration.

The statement from the American Association of Clinical Endocrinologists, which heralded a new position paper, comes after the FDA last March asked drug makers to add information on product labeling about the possible increased risk of heart attacks and strokes associated with low testosterone treatments. The drugs are used to boost testosterone levels . Read More


Want to understand drug pricing? Tell pharma to open its books
September 30, 2015 | Generics, Pricing & Patient Access, Research & Development
By Ed Silverman

Like it or not, Martin Shkreli is the new face of pharma. And for an industry already struggling with an image problem over the rising costs of prescription drugs, companies are going to have a hard time distancing themselves from one of the most controversial men in America. The reason is a lack of transparency. Drug makers do not really want to explain how medicines are priced and, as a result, they have adopted an air of secrecy in which one cowboy can create havoc for an entire industry.

“The [Shkreli] episode is really an extreme manifestation of an attitude that has taken over the industry,” said Bernard Munos, a former corporate strategy adviser at Eli Lilly who is now a senior fellow at FasterCures, a medical research think tank. Most drug companies “are not raising prices by 5,000 percent, but large prices will leave patients with the same impression.” Read More


Pharmalot.. Pharmalittle.. Good Morning.. More News On Prices and…
September 30, 2015 | FDA, Pricing & Patient Access, Uncategorized
By Ed Silverman

Good morning, everyone, and how are you today? A spot of rain is falling on the Pharmalot campus, but our spirits remain sunny. After all, you may recall a favorite saying from the Morning Mayor: 'Every brand new day should be unwrapped like a precious gift.' So go ahead and tug on the ribbon. Meanwhile, here are some tidbits to help you along. Hope you have a smashing day and do stay in touch...

Lupin has raised the price of its Fortamet diabetes drug in the U.S. by 200 percent; The so-called “right to try” laws may not work as expected – and might even strip patients of federal safety protections, and the Sovaldi hepatitis C treatment sold by Gilead Sciences caused rapid and widespread increases in Medicaid spending in 2014, but with substantial variation across states. Read More


We have a plan to reduce drug shortages: FDA’s Woodcock explains
September 30, 2015 | FDA, Uncategorized
By Ed Silverman

In recent years, drug shortages have been a recurring problem. The latest list from the FDA totals nearly 70 medicines in short supply, including the Nasonex allergy drug and the Bystolic blood pressure pill. Hoping to better predict shortages before they happen, the FDA proposed new guidelines that could go into effect next year and require drug makers to provide specific data about their production facilities, including quality complaints, in advance or instead of inspections.

The agency claims this information will help root out the kinds of quality-control problems that lead to product shortages, but drug makers are irate. They argue the program will become expensive because most companies do not compile data uniformly. They also worry about the extent to which they are held responsible for contract manufacturers. And they complain there are penalties for not complying, even though the FDA says the program will be voluntary. We spoke with Janet Woodcock, who heads the FDA’s Center for Drug Evaluation and Research, about the agency proposal and her reaction to industry concerns. Read More


Is the U.S. Trying to Thwart Poor Countries From Gaining Access to Medicines?
September 29, 2015 | Generics, Patents, Pricing & Patient Access
By Ed Silverman

In the latest flare up over access to medicines, the world’s least-developed countries are seeking an indefinite waiver from world trade rules so they can remain exempt from granting and enforcing pharmaceutical patents. But the U.S. Trade Representative is objecting to the move.

At issue is the ability of non-profits, health programs and generic drug makers working in those 48 countries to make, import or export medicines for life-threatening diseases without fear of being sued for patent infringement. An existing waiver, which was put in place 15 years ago as part of a World Trade Organization agreement, expires on Jan. 1, 2016. Read More