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Illinois' attorney general...sued Insys Therapeutics Inc, accusing it of deceptively marketing and selling an addictive fentanyl-based medication, intended to treat cancer pain, to doctors for off-label uses...The lawsuit...comes as Insys faces a number of state and investigations involving its drug Subsys (fentanyl sublingual) as U.S. authorities seek to combat a national opioid abuse epidemic...This drug company's desire for increased profits led it to disregard patients' health and push addictive opioids for non-FDA approved purposes…the lawsuit seeks to bar Insys from selling its products in Illinois and impose financial penalties on the company...

Getting a drug all the way to approval is no easy feat — for pharmaceutical companies or for regulators...in 1992, the Prescription Drug User Fee Act was passed, making it the law for pharmaceutical companies to directly pay the FDA to review their applications for drug approvals. That way the FDA has more resources to conduct rigorous and timely reviews, pharma companies get products through the regulatory pipeline faster, and patients get new drugs more quickly. Win-win-win, right?...That's one way to look at it. But others have argued that PDUFA...puts the FDA in the pockets of the drug industry...In the same way that doctors are accused of subjecting themselves to bias when they receive consulting or speaker fees from a drug company, so has the FDA been accused of kowtowing to the pharmaceutical industry... since PDUFA was passed in 1992, pharma companies have contributed $7.67 billion to the federal agency…User fees are increasingly central to the funding of the drug, biologic and device review programs, and in some cases these fees account for a larger proportion of the FDA budget than congressionally appropriated monies...

A closely watched effort in California to pass a bill that would require drug makers to explain their price hikes has been scuttled. The decision came after amendments were made during an assembly committee hearing last Friday that sources told us "effectively gutted" the legislation...The bill would have required drug makers to report any move to increase the list price of a medicine by more than 10 percent during any 12-month period. And drug makers would also have had to justify price hikes for medicines with a list price of more than $10,000 within 30 days of making such a move..."Unfortunately, recent amendments have made it more difficult for us to accomplish our fundamental goal," said California state Senator Ed Hernandez, who pulled the bill after introducing the legislation and succeeding in getting the state Senate to approve the measure two months ago...Although Hernandez said he hopes to reintroduce the legislation at some point, the withdrawal is a significant victory for the pharmaceutical industry...

In the latest dust-up over the high cost of hepatitis C drugs, the American Civil Liberties Union is threatening to sue Colorado officials if they refuse to widen access to the medications in the state Medicaid program...The saber rattling came in response to a long-standing policy by the state Medicaid program to restrict coverage only to people with the most advanced stages of liver disease, such as cirrhosis...“Basically, Colorado has been withholding treatment from Medicaid recipients until they have measurable damage to their livers. And we believe that the restrictions violate the Medicaid statute,” Mark Silverstein, the ACLU of Colorado Legal Director...“We hope they’ll do the right thing, but we’re prepared to pursue litigation otherwise.”...Since 2013, the state has spent $26.6 million treating 326 hepatitis C patients, or about $82,000 per person, according to a spokesman for the state Department of Health Care Policy and Financing, which oversees the state Medicaid program. If the state were to cover every Medicaid patient with hepatitis C, regardless of the stage of their disease, it would cost $174 million. “It could be a budget problem,” he said.

Mylan Pharmaceuticals took steps...to make its EpiPen device more affordable. Specifically, the company is increasing the amount of money on a copay assistance card from $100 to $300, and is also widening eligibility for patients to receive the device through that assistance program..."We recognize the significant burden on patients from continued, rising insurance premiums and being forced increasingly to pay the full list price for medicines at the pharmacy counter. Patients deserve increased price transparency and affordable care, particularly as the system shifts significant costs to them," Mylan Chief Executive officer Heather Bresch...These moves do not actually involve lowering the $600 list price, which has been rising steadily in recent years and caused consternation among parents across the country...By expanding programs that can help patients pay for its device, Mylan is trying to say that it is addressing the issue of affordability...Mylan hopes to blunt further damage to its reputation, which has taken a beating this week as one lawmaker after another publicly demanded the company lower the price, provide data to justify its pricing, and prepare for congressional hearings...The rebukes appeared to reach a crescendo Wednesday when Hillary Clinton called the EpiPen price hikes "outrageous," triggering yet another slide in biopharma stocks as investors braced for a new round of finger-pointing and negative news streaming from Washington...Mylan...is...trying to shift the conversation to insurance coverage...price is only one part of the problem that we are addressing with today’s actions...Bresch said that she is ready to work with Congress to fix the system, and that other key players, like pharmacy benefit managers, retail pharmacies, and doctors, also need to be part of the conversation.

It’s well known that generic drugs are just as safe and effective as their brand name counterparts. They’re the cheap knockoffs that help more people around the world gain access to innovative and sometimes life-saving treatments; the boring copycats made by companies you’ve never heard of and sold in plain bottles with little fanfare...what’s constraining the dissemination of these small molecule generics...isn’t the Food and Drug Administration and the backlog of abbreviated new drug applications, but a patent and market exclusivity system that can reward pharmaceutical companies long after they’ve recouped their research and development expenses and, at times, hefty profits…Patents and exclusivity work in a similar fashion but are distinctly different from one another. Patents are granted by the patent and trademark office...and can encompass a wide range of claims. Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA [new drug application] applicant...Exclusivity was designed to promote a balance between new drug innovation and generic drug competition...

Payers who’ve balked at a new class of cholesterol meds now have more justification. A new study concluded that Amgen, Sanofi and Regeneron would have to slash their prices by more than two-thirds to make them worth the cost...Repatha (evolocumab) and...Praluent (alirocumab) are both sticker-priced higher than $14,000 per year...study comes from the Journal of the American Medical Association...authored by academic researchers...And its conclusions are strikingly similar to previous assessments...Researchers found that using the new PCSK9 meds, rather than...ezetimibe...would save $29 billion on care for cardiovascular complications over 5 years. But the cost of those drugs would run an estimated $120 billion...Reducing annual drug costs to $4,536 per patient or less would be needed for PCSK9 inhibitors to be cost-effective…The drugmakers have taken issue with those analyses, mostly for their assumptions that all eligible patients would be put on the drugs--an overly rosy projection for drug sales. Payers’ prior authorization hurdles are already restricting uptake; up to three-fourths of patients are being turned away...So far, both drugs have underperformed expectations...

The Medivation hunt may be all but over. Pfizer is close to striking an agreement to buy the...biotech in a deal worth about $14 billion...If Pfizer and Medivation do finalize a deal, it would wrap up a months-long buyout race that pulled in much of Big Pharma and Big Biotech along the way. With its blockbuster oncology med Xtandi (enzalutamide) ready to add to a buyer’s sales, plus a much-anticipated late-stage cancer candidate and a pipeline of other prospects, Medivation has been a sought-after prize in an otherwise slow summer for biopharma M&A....

Is Novartis being investigated for paying bribes in Turkey? This seems to depend upon who you ask...the drug maker told us that it had concluded an internal investigation and found the accusations were unsubstantiated. The allegations surfaced in March in a report that an anonymous whistleblower accused the drug maker of using a consulting firm to pay bribes so its medicines could be added to formularies (in government-run hospitals)...Novartis also said last week that, while it was cooperating with Turkish authorities, the investigation "really isn’t a confirmed issue." And the drug maker told Reuters that "we are not aware of any government authority investigating Novartis. We now consider this matter closed."...On Wednesday, though, an official at Turkey’s health ministry in Ankara told Reuters that an investigation into Novartis was still "ongoing"…Bribery allegations are, no doubt, a sensitive issue. To what extent Novartis management in Turkey is clearly communicating the facts on the ground to corporate headquarters remains to be seen. But in any event, Novartis would welcome any opportunity to put such charges behind it, especially given a recent spate of embarrassing incidents...

Almost half of a special group of drugs, defined as those developed to treat rare diseases, were used for other purposes, according to a new report by America’s Health Insurance Plans. The greatest price increases among this group of drugs — called orphan drugs — were for those used for purposes other than treating the rare diseases they were developed to target...The insurers’ report charged this behavior is yet another example of drug companies potentially gaming the system for profit, the latest development in the rhetorical war between insurers and drug companies over drug costs...Orphan drugs, long thought to be treating so few patients each year that they did not present a reimbursement challenge for payers, are now being more closely scrutinized by public and private payers…study found that of its sample of 46 orphan drugs...47 percent of the drugs’ usage was for non-orphan purposes...