Branded Backlash: Small Drugmakers Fume At FDA
16 CommentsBy Ed Silverman // October 18th, 2007 // 10:01 am
The agency effort over the past year to remove unapproved drugs from the market is gaining considerable attention, and for very different reasons. When the FDA launched this initiative, the reason cited was fairly straightforward - due to a grandfathering provision in a 1962 law, there were numerous little-known but widely-used meds that were actually never approved for public consumption. Citing safety concerns, the FDA decided to go after them.
The FDA trumpeted the move as part of an overarching interest in safety. Now, though, the manufacturers of these off-the-radar meds are fighting back, arguing they are being unfairly targeted and could be put out of business if they are required to belatedly pursue the usually regulatory approval procedures. “The FDA has never required these products to be regulated as new drugs,†Larry Blansett (pictured at left), who runs Blansett Pharmacal, tells The New York Times. “It has no regard for the cost or damage they do to small businesses. There are estimates that only a few of us will make it.â€
In fact, the Branded Pharmaceutical Association, which reps about 50 small to medium-size companies, has submitted a bill to Congress that would create a cheaper and simpler process for gaining FDA approval, which can cost up to $5 million for a new drug application, the Times writes. Several members of Congress have expressed support for legislation, says BPA’s executive director, Perry Cole. “I’m confident it will be introduced,†he says while arguing that many ‘legacy’ drugs have been prescribed for at least 25 years and were safer than many current meds.
Reaction to the push back is, not surprisingly, mixed. “This is a public health initiative,†Deborah Autor, director of the Office of Compliance at the FDA’s Center of Drug Evaluation and Research, tells the Times. “Some of these drugs may not be safe. In all likelihood, these companies knew from Day 1 that they were producing illegal drugs.â€
“Many of these drugs were grandfathered in when the current approval process was instituted,†says Peter Pitts, a former FDA commish who now runs the Center for Medicine in the Public Interest, a think tank, and works for a public relations firm that reps drugmakers. “However, that doesn’t give these companies carte blanche - they still have to play by the rules,†he tells the paper
Sid Wolfe of Public Citizen agrees that “the laws have to be enforced,†but the FDA “goes for the easy targets. The collective harm all these small companies have done pales by comparison with just one or two unregulated products sold by bigger companies,†he tells the Times.
“The FDA priorities should be set according to the potential harm to the public,†he adds, contending that the agency failed to act forcefully against big corporations because of their deep pockets and political clout and noted that these same corporations pay most of the cost of the drug reviews.
The FDA began its campaign against the makers of unapproved drugs in June 2006, and immediately began ordering companies that made products that it deemed potentially hazardous to file new drug applications or take them off the market. In December, for example, it told firms to stop making unapproved products containing quinine, which has been used since the 1600s to treat malaria. The one company that made an approved quinine product, Qualaquin, was the Mutual Pharmaceutical of Philadelphia, and the FDA’s action, in effect, granted Mutual a temporary monopoly.
In May, the agency ordered drug makers to stop selling unapproved forms of guaifenesin, an expectorant and cough suppressant. Late last month, the FDA it would take enforcement action against companies that sold unapproved cough suppressants containing hydrocodone, a drug that dates back to the 1940s. The FDA’s Autor says only seven of more than 200 hydrocodone cough suppressants on the market had the agency’s approval. “One reason hydrocodone is a safety concern is because it is a narcotic, and in some cases has been labeled for use by children as young as 2,†she says.
Blansett tells the Time that his company produces two products containing guaifenesin and that he planned to stopping making both, at a cost of $2 million in annual sales. But, he adds, he will do whatever he can to keep selling hydrocodone medications, which account for more than half his company’s annual revenue. The FDA’s demand that small drug makers file new drug applications was unrealistic, he said, because most could not afford the $5 million cost. “You won’t see any small companies out there anymore if the F.D.A. gets its way,†he says.
Autor acknowledged that the legal offensive poses difficult challenges for small drug makers, but she vowed to continue. “There are a few thousand unapproved drugs out there,†she says. “So far, the FDA has taken action against approximately 500.â€
The sale of unapproved drugs has been going on for so long “in part because companies have used the laws’ grandfather provisions as a cloak to cover illegal marketing,†she tells the paper. “The agency has been working on the unapproved drugs problem steadily through the years,†she said, but has “decided to tackle the issue once and for all.†Drug makers had been put “on specific notice for at least four years that we intended to increase our emphasis on the issue.â€
According to Blansett, small companies like his historically have been exempt from the rigorous trials that the FDA requires for new drugs. Drugs like guaifenesin, which was used by Native Americans at least as far back as the 1500s, are aimed at relieving symptoms like sneezing, headaches and pain, not at curing disease. “Vioxx and other new drugs have to go through study after study with tests on 500 to 5,000 patients,†he said. “But legacy drugs have been used for many, many years on millions and millions of people.â€
But Autor tells the Times that the FDA didn’t recognize the term “legacy drugs.†Many had been introduced recently, she argues, and many of their labels listed unapproved uses. She cited versions of carbinoxamine, an antihistamine also used for colds, that were labeled for use on children as young as one month and that have been associated with 21 infant deaths.
Blansett believes the FDA exaggerated the adverse reactions of legacy drugs on children and said he would be happy to conform to any labeling changes the agency requested. “Why not just work with us?†he asks.
Pitts is sympathetic to Blansett’s appeal for the agency to work more closely with small drugmakers. “The earlier you can get all parties to the table, including manufacturers, the better,†he says
Some drugs singled out by the agency’s recent crackdown have already become much more expensive, according to the Branded Pharmaceutical Association. Mutual Pharmaceutial, for example, charges $385.13 for 100 Qualaquin tablets, each containing 324 milligrams of quinine sulfate, compared with $6 for 100 equivalent tablets that used to be available from other drug makers, according to the association. Mutual says the higher costs resulted from the “millions of dollars†it had spent to improve the safety of its quinine product.
In the meantime, the small drugmakers and the FDA. remain at loggerheads. “Why is she doing this?†Blansett asks. To which Autor replies, “It is not something that happened out of the blue.â€
Source: The New York Times
sea
Rats - now I’ll have to stock up on my tonic water.
charlesbent
the FDA is overreaching. the FDA needs to concentrate on removing proven harmful drugs from the market not eliminating competition for large companies thx
Dr. Bill
This is a more complex issue than it first appears and this article may miss the point. Many of the ingredients in these branded drugs are approved, but the unapproved ones have never been checked to make sure that the drugs are actually in the amounts said and that there are not contaminants that are harmful. Sort of like the Chinese toothpaste issue. Several branded drugs have been found to contain harmful ingredients. Some sort of bioequivalance needs to be done with approved just as done for generic compounds now. The long and extensive use of a drug does not constitute safety. Arsenic and Mercury were used as treatments for years and thought to be safe. Strychnine was used into the 20th century.
The FDA must make decision based upon data and not whether some small company that has been under their radar will suffer. The FDA is to be commended for do this now, but condemned for not doing it earlier.
jason
Dr. Bill,
Thanks for the informed comments. It is unfortunate that the only topics that can generate any discussion are on the antidepressant/antipsychotic front.
It is amazing that Synthroid came so close to being pulled off the market for the same reason. Companies should have seen this coming and started the process years ago, and not complaining about it when it is getting close. The way I see it, even though the sales numbers are small, these companies have absolutely been printing money for their owners for decades. It is always too bad when the gravy train ends, but sometimes you have to be thankful it ever existed.
Again, nice to see people with broad and diverse medical/pharma interests on the board.
Lisa Van S
Jason,
Med Guides have Medical/Pharma even Congressional interests,Members of Congress have children,so they too are concerned about the safety of the Medicines they give their children.
Mediacations Guides are not just limited to Psychotropic drugs in Children; See Here
http://www.fda.gov/cder/meeting/medication_guides_200706.htm
I noticed “YOU” a self-proclaimed, responsible Physician declined to comment.What do Docs really think…Should Parents have an accurate description of side effects so they can safely monitor their children?….
Maybe the bigger question is this?
What’s more important,Profits for Industry and their “APLOGISTS” or the LIFE OF A CHILD”?
jason
The appropriate information to the appropriate parents/patients is the most important. Quite honestly some parents can not handle and evaluate the risk/benefit relationship. If you think every child has a loving and nurturing home environment I would invite you to look around.
If you have a depressed child with social issues that require referral and treatment of a physician - then yes, it should be commonsensical that they should be watched. I would recommend that strategy with or without medication. Are you recommending a suicide prevention guide to be given to every parent and patient who consults with a physician with a psych complaint? That seems most appropriate of all doesn’t it?
As anyone who has picked up a prescription - that information whether the standard pharmacy printout or a medguide is tossed away before they hit the car. I could really care less either way with the med guides because I believe they have virtually no effect. Kind of the crying wolf syndrome - put enough med guides and black boxes out there and they all lose some of their effectiveness.
So yes the goal is safety, I guess you and I will have to disagree on who is best judged to make medical decisions. Joint decisions with good communication is key to compliance and efficacy in virtually all conditions.
I am sorry to have posted this here, I know there are plenty of good antidepressant/antipsych/medguide posts.
So in summary - I believe these meds such as hydrocodone syrup should have to go thru the FDA like all other meds do today.
jason
Lisa,
Also actually took a look at your link and your presentation. I don’t know if you have heard this from actual practicing physicians, but those marketing toys don’t sell any drug. If you think giving my receptionist a foam block that will never make it to my desk is making me write for Risperdal for infants you are crazy. First of all if it is anything other than a pen, the receptionist, transcriptionist, ect is taking it for their kids or selling on e-bay (take a look sometime, you might find a new image). Secondly, there is too much noise from too many companies that it is all lost unless it is rooted in science. Pfizer is the undisputed marketing king, but their antipsych is losing to others - that is science and experience winning over marketing. I only use that example because that is the only part of medicine you are concerned with obviously.
Also, take note of fair balance as even the pharma companies are doing. Showing 1 article that expresses your viewpoint is not really fair balance.
But good luck with your fight, but FYI in my practice narcotics have been HUGELY devastating and addiction is a much bigger problem in society than antidepressants. Could just be my vantage point, but then again we are all prone to think our world is the only one that is important.
Lisa Van S
Jason,
“Also,take note of fair balance as even Pharma Companies are doing.Showing one article that expresses your viewpoint is not really fair and balance”
Wow,It is quite clear that You didnt attend this two day hearing,because if you had, you would not have made such a foolish statement.
That hearing was fair and balanced and the views of all, were heard,and respected.(See Agenda)
Big Govt,Socialised views and Socialised medicine,…hmmm….. “you must be a Hillary fan!!!…”
jason
Wow, you are right I didn’t attend this 2 day meeting. You have to remember that I am a PRACTICING physician working a solo practice in the rural midwest. Taking care of farmers, delivering babies, trying to patch people together so they can make it to surgery. Kind of hard to explain to them that there is no one on call for the ER because your doc wanted to take a trip to see how efficient, effective government works. Here is my typical Sunday and today have gone: I made it to church and got thru lunch with my family before an AMI caused me to come in. Waiting for a farm accident to be transported here, hopefully within the next 30 minutes for everyone’s sake.
And no, I didn’t go thru all of the PPT presentations, I just saw your name attached to one and thought I would take a look. I find PPT on their own without speaker notes to be somewhat worthless, as I know when I am doing a presentation I save the important noteworthy things to add to the content of the slide. Most good speakers I have seen don’t read off the slide, so if you don’t have notes or audio why waste the time. But again, I have never seen or been involved in big government, just teaching residents here and there. But I am glad all vantage points were represented and am even more hopeful that someone with a medical background was there as well. But again, med guide or not, it won’t change my life or practice in the least. That’s one reason I had no opinion to add when it was posted.
I wish I had a chance to devote all my time and energy to 1 cause but I don’t. I wish I could delve into politics, but I don’t know why anyone cares about why Alan Keyes would be the best president we could elect - I obviously don’t share the political views of the majority. But again, I am not sure how that opinion adds to the discussion that little pharma companies should have their drugs reviewed by the FDA.
Lisa Van S
Jason,
“So yes the goal is safety,I guess you and I will have to disagree on who is best judged to make medical decisions.Joint decisions with good communication is key to compliance and efficacy in virtually all conditions”
Would you please elaborate on this statement for me,have been a bit under the weather and its not clear to me what you are trying to say.
Thanks
Lisa Van S
Jason,
Sometimes,…just sometimes..Pictures can speak louder than words!!…..
Check out GSK Marketing/sales PPT,Absolutely Fascinating.
I dont believe your wife… or any other woman will find the last PDF Very Funny…
I would be curious to know what the Female Pharm Reps think.
http://abcnews.go.com/images/primetime/paxil_moneybag.pdf
http://abcnews.go.com/images/primetime/paxil_remarkable.pdf
http://abcnews.go.com/images/primetime/paxil_bpg.pdf
http://abcnews.go.com/images/primetime/paxil_wheresmy.pdf
Lisa Van S
Ed,
Your comment is awaiting moderation….
You’ve got to be kiddiny!!!..
Bob
Lisa-
I think you need some of the psych meds you rail against…
Donna
Bob, I’m sure your alot nicer then you come off to be, maybe when you retire your true color’s will show thru…………Your’s Truly Crackpot….
Lisa Van S
Bob,
Good Morning!..Hope you had a pleasant evening.
I would love to have a serious open dialogue regarding these documents,and would like to hear what others have to say.
You have documents that 1)promotes the off-lable use of Paxil in children,knowing full well that it causes suicide and violence and has no efficay.2)Desparages Women 3)Places Profits before human life,especially children.
So Bob…feel free to call me any name you see fit,Our constitution gives you that right.
and Jason,You expressed your opinion on my FDA PPT!!…
How about an opinion on GSK’s docs!!!…
Laura
I had no idea this was happening. Evidently, neither did my physician or my pharmacist. I am not sure if that means they were just not paying attention or if neither of them knew this would affect me.
What this has done is this: I have two months of medication left of the ONLY drug that keeps me alive. I have autoimmune thyroid disease from Hashimoto’s contacted 21 years ago. The only drug that keeps me alive is the old-fashioned thyroid (Armour thyroid.)
I had NO say so in them taking a drug off the market that has been around since before they were even an agency. I also have NO right (according to the FDA) to know if indeed any of the manufacturers have applied for approval.
The person I contacted at the FDA said that I could get my meds from a Canadian online pharmacy through a very convoluted process that will involve my ordering these drugs every three months with a new script and my doctor okaying this every three months. I don’t know about you all, but my doctor is probably NOT going to embrace giving me the “okay” to get a drug that’s been “BANNED” here in the United States from an online pharmacy in another country…even if it is Canada. I’m sure the legal ramifications lightbulbs will go off over her head the very first time I approach her with that request.
This is a deadly decision for me. I am horribly upset that I seem to have no other recourse but to die.
My family and friends are shocked. How do you explain that you feel fine, you look fine, you are active and loving life and because you can’t get a hold of a medicine you’re going to die?
No. Nothing else works for me. Trust me: the docs pushed and pushed Synthroid on me for years and I was very sick with a goiter that never went away, choking constantly, sleeping up to 18 hours a day, horribly overweight, hair loss, sick all the time. It was no life, but I did what the docs wanted and kept on with their synthetic medication.
I’m angry and I’m scared and I’m reaching out to anyone who might have any ideas on what I can do.
Thank you for you time with this.