Once again, it is time to catch up on the news from the pharmaceutical industry. And so, here is the latest monthly compendium in which we attempt to highlight some of the more noteworthy and fascinating news with a focus on the Food and Drug Administration (FDA), preemption and the Supreme Court.
1. FDA to Allow Generic Drugmakers to Update Labeling
The FDA is following through on plans to issue a proposed rule to revise regulations to allow generic drugmakers to update labeling. The rule would update current regulations that prevent generic drugmakers from doing so, even if they become aware of a potential risk not mentioned in labeling. By contrast, brand-name drugamkers can update warnings and precautions on labeling before obtaining FDA approval.
The moves comes in response to a US Supreme Court ruling two years ago that generic drugmakers are not required to strengthen product labeling, even when alerted to side effects, so long as the same change has not been made to the labeling for the branded medicine. The decision sparked an outcry that product labeling would be insufficient to warn patients about the risks associated with numerous medications.
The summer may be in full swing, but the torrent pace of news and interesting developments has not subsided at all. Hot days simply yield hot stories.
1. GlaxoSmithKline Bribery Scandal
Unarguably, the most sensational item over the past few weeks has been the GlaxoSmithKline bribery scandal unfolding in China. As of mid-July, four Glaxo executives, all of whom are Chinese nationals, were detained and authorities hinted that other drugmakers may be examined as they review records held by travel agencies implicated in the drama.
The scandal is all about boosting prescriptions of Glaxo meds in China, where domestic drugmakers are notoriously corrupt and doctors are paid relatively low wages compared with the West. But the episode is renewing scrutiny of Glaxo – and by extension, all multi-national drugmakers – at a time when they are jockeying to expand in China and are also under a microscope for their corporate practices.
Once again, it is time to catch up on the onslaught of news emanating from the pharmaceutical industry. By now, most are probably are aware of a pair of Supreme Court rulings, but we will very briefly recap those and then move on to some other highlights. Here you go…
After years of debate and controversy, the US Supreme Court ruled that drugmakers can face lawsuits over so-called pay-to-delay patent settlements, but that such deals should not necessarily be assumed to be illegal. The decision largely vindicates the position held by the Federal Trade Commission, which argued the deals are anti-competitive because generic drugmakers are given incentive to file lawsuits against brand-name rivals and then settle for a quick profit, rather than challenge a patent in court. The FTC calculated the reverse settlments, as some call them, cost consumers $3.5 billion annually.
“This court declines to hold that reverse payment settlement agreements are presumptively unlawful. Courts reviewing such agreements should proceed by applying the ‘rule of reason,’ rather than under a ‘quick look’ approach,” Justice Stephen Breyer wrote in a 5-to-3 decision. “…The likelihood of a reverse payment bringing about anticompetitive effects depends upon its size, its scale in relation to the payor’s anticipated future litigation costs, its independence from other services for which it might represent payment and the lack of any other convincing justification” (here is the ruling).
Since my last article here on IPWatchdog.com, the pharmaceutical industry has been simply overflowing with interesting developments, including the US Supreme Court hearing arguments concerning three significant cases.
The first case argued at the Supreme Court will determine whether generic drugmakers can be sued for alleged flaws in the design of their medications. At issue is whether federal law preempts such claims from proceeding in state court and if drugmakers can be held liable if they decline to withdraw their medicines from the marketplace.
Of course, the same concept could be applied to brand-name drugmakers, which is why the entire pharmaceutical industry is on edge. In fact, the Obama administration filed a brief in support of drugmakers over concerns the FDA regulatory review process could be undermine if medicines deemd safe and effective could later by considered ‘unreasonably dangerous.’
The court reviewed an appeal by Mutual Pharmaceutical to overturn a $21 million jury award to a New Hampshire woman who in 2004 had taken a generic painkiller called sulindac, but developed Stevens-Johnson Syndrome and toxic epidermal necrolysis. She’s nearly permnanetly blind and suffered burn-like lesions over most of her body, underwent numerous surgeries, and is now unable to read, drive or work, and must use a feeding tube, her lawsuit says.
Yet another busy month has passed since our last stop here at IPWatchdog. So let’s recap some of the more interesting developments. The last few weeks, in fact, have been bookended by concern over a batch of diabetes drugs and links to pancreatitis, but also pre-cancerous cellular changes in the pancreas.
First, a study in JAMA Internal Medicine indicated the drugs can double the risk of developing pancreatitis, an issue that has plagued these meds for years. Insurance records for more than 2,500 diabetics between 2005 and 2008 were examined and found patients hospitalized with pancreatitis were twice as likely to have taken the drugs than a control group that did not have pancreatitis. The study did not examine other meds, such as Novo Nordisk’s Victoza, that were not available at that time.
The issue raised questions about whether the results might alter treatment practice by physicians. Of course, the drug makers issued statements standing by the safety of their medicines, while acknowledging the risks have been detected in the past. The American Association of Endocrinologists and the American Diabetes Association issued a joint statement noting the analysis was a retrospective study, not a prospective, randomized controlled clinical trial.
Since we last met, there was yet another development in one of the more fascinating stories to grip the pharmaceutical world. The FDA decided not to pursue a re-hearing before a federal appeals court that recently ruled the federal government could not prosecute a sales rep who promoted off-label uses of a medicine because his speech was not false and misleading. The agency let a January 16 deadline pass without filing a motion.
At issue was a decision by the US Court of Appeals for the Second Circuit to overturn the 2008 conviction of a former sales rep for allegedly encouraging doctors to prescribe a drug on an off-label basis. A panel ruled 2-to-1 that his conviction violated his First Amendment rights and that the federal government did not attempt to prove that his remarks were false and misleading.
Since then, the decision has raised questions about a fundamental premise long asserted by the FDA and the US Department of Justice that off-label promotion is prohibited by law, which has been the basis for numerous settlements with drug makers over the past decade. Consequently, the court ruling prompted speculation about the strategic approach the FDA would take in response.
Since we last stopped by, there was a holiday break. But not surprisingly, 2013 began with a predictable rush of interesting news. So here are some of the most recent highlights, from court rulings and medical study findings to FDA doings and steps taken to developed new parameters for prescribing and clinical trials in various places.
For some, the year began on a disappointing note. That’s because the Obama administration again missed a deadline for releasing much-anticipated Sunshine guidelines for industry transparency. Late last year, the Centers for Medicare & Medicaid Services sent a final version to the White House for approval. But despite anticipation that guidelines would soon become public, the new year passed without a peep. Once again, all bets were off.
The guidelines, which became law as part of the Affordable Care Act, are supposed to set ways for gathering and publishing data that contain financial ties between physicians and drug and device makers. This would include ownership or investment interests held by a doctor or family member. Penalties for violations can range from $1,000 to $100,000. The CMS estimates it will cost industry and providers about $224 million in the first year and $163 million annually thereafter to comply.
Litigation always factors into the pharmaceutical world, but the US Supreme Court commanded a special place in recent days. The high court figured in no fewer than four contentious issues that, not surprisingly, play a vital role in how drug makers can and will operate.
Let’s start with a case that is not yet before the court, but many predict will be headed there thanks to one of its earlier rulings. Earlier this month, a three-judge panel of the US Court of Appeals for the Second Circuit overturned the conviction of a former sales representative, who argued that prosecuting him for remarks made about off-label use violated his free speech rights.
In their decision, the 2-to-1 majority cited a US Supreme Court ruling early last year that struck down a highly controversial Vermont law, which restricted the sale of prescription drug data identifying prescribers and patients for commercial marketing purposes. Specifically, the court ruled that “speech in aid of pharmaceutical marketing… is a form of expression protected by… the First Amendment.”