Latest Drugwonks' Blog
WASHINGTON—The Food and Drug Administration approved the first generic version of the big-selling blood thinner Lovenox, in a victory for a unit of Novartis AG.
The Novartis unit, Sandoz, and partner Momenta Pharmaceuticals Inc. have been in a tug of war for years with a California-based company, Amphastar Pharmaceuticals Inc., to win FDA approval for generic versions of Lovenox.
Amphastar has accused the FDA and its drug-division leaders of favoritism in the past year, noting that Momenta worked closely with the FDA on safety issues and investigations in recent years. Momenta has said its relationship with the FDA is appropriate.
Sanofi has fought to protect Lovenox from generic competition, saying that the drug is too complex to be completely copied safely. Researchers with ties to Sanofi recently filed citizens' petitions to the FDA asking the agency not to approve any company's enoxaparin.
The good news: FDA Social Media Guidance. The bad news: FDA Social Media Guidance.
Here’s how my interview with emarketer begins:
eMarketer: The FDA is expected to issue guidance on the use of social media this year. What do you think it will look like?
Peter Pitts:
There are a lot of ifs. The first if is, is this really a good thing? A lot of times when you ask for regulation and you get it, you may not be happy with it. If marketers are waiting for FDA guidance with the assumption that it’s going to make their jobs easier, that’s very much open to question.
And here’s how it ends:
Peter Pitts:
The concept of being incomplaunce vs. doing the right thig for the
For everything in the middle, see here.
Congressman John Boozman (R,AR) from CMPI on Vimeo.
Drafters had hoped the provision would generate $17 billion to help pay for reform. But James Gelfand, director of health policy at the U.S. Chamber of Commerce, says he's rarely seen an issue on which members are so strongly united in opposition, calling them "apoplectic" over the provision. An administration source tells Pulse that the comments from the business community are "obviously something we take seriously" and that there's been significant outreach to them. Treasury has already made one change: Transactions on credit and debit cards won't have to reported on a 1099.
James Gelfand Director of Health Policy, US Chamber of Commerce from CMPI on Vimeo.
According to Craig Kessler, professor of medicine and pathology at Georgetown/Lombardi, the absence of mandatory clinical trials for biosimilar drugs could compromise their safety and effectiveness.
He said that the difference in manufacturing processes between companies can alter the drugs "in ways that technology can't detect.”
The healthcare reform law outlined a pathway for FDA to approve next-generation biopharmaceuticals modeled on original breakthrough drugs. But the legislation leaves the agency with a great deal of leeway -- including the flexibility to decide whether clinical trials are necessary at all.
"If you don't have clinical trials to take a look at all of these other off-label uses," Kessler said during a Capitol Hill discussion hosted by the Congressional Health Care Caucus, "then you don't really know what the equivalency in dosing is going to be like, and what the safety — the long-term safety — [issues] will be."
We need to proceed with biosimilars – but with care and caution.
No profit grows where is no pleasure ta’en;
In brief sir, study what you must affect
Close the FDA Approval Gap
The extensive review by a panel assembled by the Food and Drug Administration of the diabetes drug Avandia highlights the critical importance of government regulation and oversight of the drug industry.
Questions have been raised about the safety of Avandia since 2007, and a process to assess these risks versus patient benefits was undertaken by the objective professionals at FDA. But one important question underscores all such inquiry: What happens when the drug safety cop is taken off the beat?
Even though our system of pharmaceutical review and approval is regarded as the most effective in the world, there exists an incredible -- and potentially deadly -- loophole: unapproved drugs.
Recent news stories regarding the recall of 1,500 lots of Johnson & Johnson's children's and infants' Tylenol, Motrin, Zyrtec and Benadryl due to bacterial contamination, and the subsequent suspension of the their manufacture, reinforce the importance of the US Food and Drug Administration's (FDA) regulatory oversight over drug products--even years after they have been approved for sale. But due in large part to grandfather provisions going back 50 years, unapproved drugs - those that have been marketed prior to the establishment of today's FDA - are actively promoted, prescribed and taken by millions of patients in the U.S. These drugs escape FDA scrutiny otherwise imposed for all approved prescription and over-the-counter medications.
Most alarming is the fact that unapproved drugs account for nearly 72 million prescriptions per year. Unapproved drugs lack the specific quality controls of an FDA-approved drug, including manufacturing oversight that ensures the appropriate amount of active drug in each tablet, the purity of ingredients and consistency from dose-to-dose. And perhaps equally troubling is the fact that - unlike every other medication available for human consumption in the United States - unapproved drugs are not required to be accompanied by dosing information supported by human clinical studies.
The consequences of this approval gap can be tragic. Hundreds of deaths have been linked to the more than 500 unapproved drugs that FDA eventually banned. Yet to this day dozens of unapproved drugs are marketed under the regulatory radar. As recently as this past March, FDA took action against manufacturers of unapproved sublingual nitroglycerin tablets for treating certain heart conditions. FDA stated that it had seen "significant quality and efficacy problems" with unapproved nitroglycerin products and, as a result, recalled them from the market. Meanwhile, an FDA approved version had been available for years right alongside the unapproved, unregulated, and we now know, unsafe versions.
And the front-line gatekeepers of the nation's prescription drug delivery system--America's pharmacists--are themselves largely unaware of this dual standard for safety among the products on their shelves. A 2006 nationwide study of 500 pharmacists found that 91% of them incorrectly assumed that all of the products they dispense are FDA-approved.
They should be approved, of course. That's why in June of 2006, when I was head of the FDA's Center for Drug Evaluation and Research, we launched an initiative to finally address unapproved drugs. The Agency issued a Compliance Policy Guide (CPG) to review the safety and efficacy of unapproved drugs that continue to be available, in an attempt to bring these products into the modern world of drug safety with clinical, regulatory and manufacturing oversight.
Certain medications that have never undergone FDA evaluation should continue to be available for patients--when no substitute exists--so long as there are no known safety concerns. Many patients simply have no alternative treatment. But as soon as an approved version becomes available, FDA needs to act immediately and enforce its policies by withdrawing all unapproved formulations from the market. Regulatory oversight alerted us all to the risks associated with certain products manufactured by J&J. If no one is watching, how can we be sure it will never happen again?
"Patients should continue taking all currently prescribed medications unless instructed otherwise by their healthcare provider," said Dr. Robert A. Vigersky, immediate past president of the Endocrine Society. "Stopping diabetes medications can cause significant harm and result in higher levels of blood glucose that may cause severe short-term health problems and could increase the risk of diabetes-related complications in the long term."
“Effectively, this drug is gone.”
U.S. sales of the drug have plunged from $2.2 billion in 2006 to $520 million last year because of fears generated largely by Nissen. Meanwhile Actos, made by Takeda, the company Nissen has consulted for, has seen sales of it's product soar from $1. 9 billion in 2006 to $3.4 billion last year.
I think they got their money's worth.
Whether patients did is another matter. During the same time, the combined number of scrips for TZDs declined overall by 40 percent and scrips for oral diabetes agents fell by 20 percent. (I am going to double check this figure..) Did cardiovascular events among diabetics decline by 25 to 43 percent as might be predicted? No.
While there was an effort to depict Avandia's problems as a matter of deadly risks purposely hidden by GSK the issue was really two-fold. First, the fact that the FDA had to react to the risks of Avanda as framed by Nissen rather than the overall risk and benefits of each drug in the class in the context of treating diabetes and all it's complications. It had to focus on heart risks and whether surrogate endpoints were reliable, etc. all of which were issues framed to undermine confidence in the FDA and shift power to Nissen and outside or rogue forces. Second, and only after wading through this thicket, was the FDA able even to carry out it's public health responsibility and provide the advisory committee with that task. To that end, Commissioner Hamburg's leadership on this issue, along with the stewardship of Drs. Woodcock, Temple, Jenkins and DelPan should be applauded. And once again David Graham demonstrated why he is best suited for getting coffee in the FDA's division of psychopharmacology..
The big question is whether the treatment and management of diabetes is better off after the fearmongering.
More people have diabetes and fewer people are taking drugs. Is that a good thing?
Maybe Nissen should worry more about patients instead of his publicity and his bank account.
The vote ended up not even being that close. Ten panel members voted to keep Avandia on the market but with serious revisions to its label as well as possible restrictions on its sale. Seven voted to simply add further warnings to the drug’s label. Three voted to allow further sales without change. Twelve members voted for market withdrawal.
To most Americans it means that it’s almost time for lunch.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
