Name brand drugs got more expensive last year. A lot more expensive.
Prices for the 200 brand-name drugs most commonly used by the U.S. elderly rose an average of 6.2 percent last year, almost twice as much as the rate of inflation, a report says.Sanofi-Aventis SA increased the price of its sleeping pill Ambien 30 percent, more than any other medication of the 200, the AARP, a lobbying group for people 50 and older, said in a report today. Boehringer Ingelheim Pharmaceuticals Inc. boosted the price of its Combivent inhaler for lung disease 18 percent, the second-biggest increase.
The AARP, based in Washington, is pushing the U.S. Congress to pass legislation permitting the government to seek discounts on drugs bought by Medicare, the federal health program for the elderly and disabled. The law creating Medicare's drug benefit, which began last year, bans such negotiation. (Lisa Rapaport, Bloomberg)
That's some information. Here's some more information, another (separate) Bloomberg story:
The commissioner of the U.S. Food and Drug Administration said he opposes legislation allowing routine approval of copies of drugs made by biotechnology until the agency can be sure they are safe and effective.
Andrew von Eschenbach said in an interview that the FDA is reviewing the "scientific foundation" that would be needed for the agency to create an approval process for the medications.
"We're continuing to work through these scientific issues," von Eschenbach said in Washington today. "Do we have sufficient data, information, to enable the FDA to determine if this product used in this patient will have an outcome similar to what occurred with the innovative product?"
Generic biotech drugs could reduce prices by almost a third and cut into the profits of makers or brand-name biotech drugs such as Amgen Inc. and Genentech Inc., analysts said. Some of the medications are among the costliest on the market and include treatments for cancer and arthritis. (Justin Blum and Catherine Larkin, Bloomberg)
The legislation, introduced last month in the House and the Senate, would allow the FDA to do what it already is allowed to do with generics made by conventional chemical means for identical drugs made with biotech methods. von Eschenbach wants to do this on a case by case basis. Europeans already allow the routine approvals for generic versions of many classes of biotech drugs, whose prices are often 20% to 30% lower than the brand name versions. The FDA's scientific argument is mirrors that of the biotech industry association that the complexity of biotech production might lead to ineffective or harmful generic copies. The problem I have is not whether this is more likely than for chemical synthesis (I'm not sure why this would be). I haven't examined the evidence on both sides. My problem is both simpler and more complicated. I don't have any reason to trust the FDA as an agency more interested in safe guarding my physical health more than safe guarding the financial health of Big Pharma. Sadly, the suspicion that the FDA is not on my side has become a rebuttable presumption. Trust is an important resource, and the FDA has squandered theirs.
Probably the most bizarre FDA news of the day, however, is von Eschenbach's objection to Senator Kennedy's legislation authorizing the FDA to regulate tobacco. The purpose of the legislation is to give the FDA authority:
. . . to reduce harmful elements in tobacco products and smoke, help smokers quit, police industry claims and block advertising and sales aimed at children. It doesn't specify that the FDA could ban tobacco.
"When a product, when used as directed, results in death, it's hard for me to see how to regulate that as being safe and effective," said von Eschenbach, a physician and cancer specialist. (Jay Newton-Small, Bloomberg)
Does that mean that a drug, when used as directed, results in death it should also not be regulated? Seems so and has been so. But that's another story. In this instance, von Eschenbach won't regulate cigarettes because they should be banned, not regulated. While there is merit to the position, in the abstract, cigarettes, some 378 billion of them last year, are not smoked in the abstract.
Attempts to allow FDA regulation were blocked by the House Republican leadership in 2000, 2002 and 2004. The story is weirder yet, because the largest tobacco company, Altria Group's Philip Morris USA, now supports the legislation. To understand what's going on you also have to know that the second largest cigarette company, Reynolds American Inc. of Winston Salem, North Carolina, opposes it.
The legislation's restrictions on advertising and marketing would lock in the market advantage of Philip Morris, said Tommy Payne, who heads government affairs for Reynolds.
Philip Morris of Richmond, Virginia, produces the Marlboro brand, which accounts for 40 percent of U.S. cigarette sales, more than the next 10 cigarette brands combined.
A landmark agreement on cigarette marketing restrictions in 1998 was part of a huge health settlement with many U.S. states, who sued the industry for the Medicaid costs related to cigarette induced illness. There was abundant evidence that knowledge of tobacco hazards was well known to the industry but fraudulently concealed. The 1998 agreement was to forestall even more stringent measures.
So the FDA won't get involved with cigarettes. They will get involved with generic drugs. Meanwhile the price of brand names drugs is rising twice as fast as inflation.
Hmmm.
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This is a quibble, revere, not a gripe. Jody Lanard posted a very interesting diary on Flu Wiki earlier today. She said that governments don't get our trust, they earn credibility. We hold them accountable. I like that formulation.
To answer your paranthetical comment: it's because you can't determine the exact structure of a protein drug the way you can for a small molecule drug. When prescription Claritin becomes generic loratadine, the generic drug maker can easily prove that their active ingredient is exactly the same. It's also relatively easy to identify and compare any impurities or related substances between the original & the generic.
With a protein drug, it's not so simple. You can't actually determine an exact structure. The protein almost always exists as a mixture of similar but chemically distinct species. In addition, proteins can take on different shapes, and the shape can dramatically affect activity or safety. (There are real-world examples of this, e.g. with Epogen.)
It's difficult or impossible to fully characterize the range of species in a protein drug. So, it's difficult for a generic drug maker to show that his drug is physically and chemically equivalent to the original.
It's also complicated by the fact that the range of species may be very dependent on exactly how the protein is made. Not so long ago, the branch of FDA that used to regulate all protein drugs had a saying: "The process is the product." In other words, if you changed almost anything about the process you used to make the protein, you couldn't be sure it would still behave the same, even if it looked the same in all your physical & chemical tests. Thus, it was in effect a new drug.
FDA has moved away from that a great deal, but some of that bias still exists, and it still has some legitimacy.
Agreed. I know enough to recognize that there are legitimate concerns about generic protein drugs. I don't know enough to judge how serious those concerns really are today. FDA has been talking about this issue for at least 10 years, but hasn't made serious progress.
Companies interested in protein drugs are generally split on this issue. The big ones like Genentech, Amgen, Biogen, etc., tend to argue that biogenerics are too dangerous. Of course, that's fine for them, because it means the only way a competitor can sell the same drug is to go through the entire approval process (rather than a more abbreviated process like the one that applies to generic small molecules). That makes for a pretty significant barrier to market entry, and presumably allows them to maintain higher market even after any patents expire.
On the other hand, smaller companies that have ideas for producing useful protein drugs more cheaply would like FDA to come up with a biogeneric approval process. I understand this has led to significant disagreements between members of industry organizations like BIO, especially when FDA asks for industry recommendations.
Interestingly, there's already sort of a model for generic proteins: insulin. Insulin didn't really get caught up in this whole issue, in part because it was already an approved drug when the protein-regulating part of FDA (CBER) was created. Authority over insulin stayed with the part of FDA that mainly regulated small molecules (CDER). As I understand it, CDER was much more open to the idea that different companies could make insulin in different ways, and it would still be equivalent. I don't think it was ever treated as a true generic, but I don't think it was treated as a brand new drug each time, either.
The funny thing is, authority for most protein drugs was transferred from CBER to CDER a few years ago. (CBER mainly focuses on vaccines, cell based therapies, blood products, & gene therapies these days.) But that hasn't seemed to move the debate along too much.
qetzal: Thanks. Glad I asked. Informative comment and appreciated.
Do different strains of yeast do different post-translational modifications or have different chaperonins?
I know you can get different results in yeast (a eukaryote) than bacteria (prokaryotes), given an identical DNA strand.
I believe so for the post-translational modification, especially since there are several different species of yeast that get used: Saccharomyces, Schizosaccharomyces, and Pichia, at least. I don't know about differences in chaperonins.