Meet Mike Coleman

This morning, the blog Pharmalot had a posting entitled "Meet Mike, Your Generic Biologics Lobbyist", and I thought it would be appropriate to reiterate the need for Congress to move forward on this very issue. It was indeed a surprise to many (including me), but as I posted last week, even President Bush's 2008 budget calls for Congress to pass legislation to enable generic biopharmaceuticals.

Last week, Insmed had one of its scientists, Mike Coleman, offer a "researcher's view" of the value of generic biopharmaceuticals. Coleman makes for an unusual lobbyist. But apparently Insmed, which has projects under way to develop several different generic biopharmaceuticals, is banking on a new 'educational campaign,' another way of saying public relations (PR), to influence Washington and the public on this subject.



Although insulin is not considered by law to be a biopharmaceutical (it is grandfathered under the Federal Food, Drug & Cosmetic Act, not the Public Health Services Act which governs vaccines and most other biopharmaceuticals) but it has nevertheless been caught up by the FDA's refusal to outline procedures for generics manufacturers to obtain approvals. (More details can be seen in my previous postings on this topic, which can be found here.)

Last year, a bill introduced by California Rep. Henry Waxman, and New York Senators Charles Schumer and Hillary Clinton was never voted on. In essence, the bill, called the "Access to Life-Saving Medicine Act" would mandate the FDA to outline procedures for generics manufacturers to obtain approvals. It does not mandate additional clinical trials, rather it leaves that up to the FDA to decide on a case-by-case basis when additional trials are necessary to secure an approval.

This is no small issue, but the U.S. is now several years behind the European Union when it comes to moving forward on generic biopharmaceuticals. The main reason seems to be lobbyists for the drug and biotech industry who have managed to delay what is likely to be the inevitable, while screwing the American taxpayer (largely via the cost of Medicare Drug coverage) as well as our healthcare providers out of as much money as they can for as long as possible before the other shoe drops.

Last March, Novo Nordisk A/S sent one of its exectutives, Inger Mollerup, to Congress to testify (and scare) legislators about the risks of making it too easy for generics makers. As a business, the company's motives were clear: make it as costly and time-consuming as possible for generics makers, which will help fatten Novo's bottom line. But there were some noteworthy disclosures made in that testimony. I will give you some excerpts here:

Novo Nordisk's Vice President for Regulatory Affairs admitted to Congress that biologic medicines are created without tools and models that predict safety; clinical laboratory tests are insufficient to determine immunogenecity/other issues; and the FDA has also admitted no general safety threshold even as low as 0.1% is sufficient because protein impurities are highly reactive to the human body at low exposure. In essence, Novo claims that other than through human experimentation (patient guinea pigs) we have no technology to prove the fact that synthetic insulin works. But insulin, unlike most biopharmaceuticals, is already fully characterized.

Different, Higher Standards for Generics?

Mr. Mollerup also stated that generics makers should be required to undergo batch testing and Adverse Events (AE) reporting (to paraphrase his message) in order for patient safety to be traceable. Gee, that sounds like a good requirement, doesn't it? However, Mr. Mollerup failed to disclose is that since 1998, his company and the other insulin manufacturers have been exempt from doing batch testing. Isn't that slick? Tell Congress that they must require generics makers to do something that they aren't required to do. The bigger question is why the FDA has enabled this in the first place if it's to ensure patient safety?

There is plenty of evidence what the company is trying to do. In January 2006, Novo Nordisk's Chief Financial Officer, Jesper Brandgaard, in an interview with CNBC/Dow Jones, actually admitted that his company intended to eliminate human insulin and replace it with more expensive, patent-protected insulin analogs:

"We are about to convert the market from human insulin onto insulin analogue. If we look at it globally, we have more than 40% of the market now converting to analogue. So we are actually in a different situation from most other companies. We are taking our portfolio from being generic product, human insulin, onto a patent-protected insulin analogue. So we are actually getting our portfolio on-patent, not off-patent."

I have already noted in my coverage of Q3 2007 earnings, archrival Eli Lilly and Company seems to be holding Novo up from fulfilling its ambition to put everyone on a patent-protected insulin analog, as Lilly's Humulin franchise remains a highly-profitable business, and Lilly cannot afford to eliminate medicines that collectively sell over $1 billion annually at this time. But it's obvious that the business plan is to convert everyone to more expensive, patent-protected insulin analogs, even though there is NO validated scientific proof that they improve glycemic control. Its all about money, but if that's the case, who is going to make regular human insulin? Perhaps only generics makers.

The Meaning of Brand-Names

One other point: your insulin may carry the brand-name company's name on its label, but its relatively easy for the drug company to outsource the manufacturing to third-parties who may not have the same quality-controls. For example, Eli Lilly and Company does not make all of its Humulin® in their Indianapolis factory (or factories owned by Lilly abroad). In fact, a document on file with the U.S. FDA enables Lilly to outsource manufacturing of Humulin R to Abbott Laboratories (which was spun off in 2004 to become Hospira One 2 One Contract Manufacturing Services), in McPherson, Kansas as an additional, FDA-approved manufacturing site. Its possible that others have been filed with other manufacturers, both domestically and internationally.

It's about time to finally clean up the whole act at the FDA. No more different standards for brand-name drug companies like Eli Lilly and Company, Novo Nordisk or Sanofi-Aventis while requiring a different, more-stringent standard for generics makers! Batch testing should be mandated as a requirement for all manufacturers, and let the proposed legislation enable the FDA decide when additional clinical trials are required to secure the Agency's approval.