To protect veterans, Congress must close biologics loophole

Congress is considering legislation to create an approval process for follow-on biologics, a new generation of drugs made from living organisms. We are strongly in favor of such an approval pathway, but are concerned that it may not cover a number of biologics.

Specifically, there are dozens of biologics that were approved as drugs and would be excluded from the new pathway for a period of 10 years. Among this class are many biologics, including varieties of heparin, growth hormones and insulin. Follow on versions of these products should be subject to the same patient safety standards as all other biologics. With this in mind, the legislation should bring these products under the biologics regulations now (not in 10 years) so that proper clinical assessment can be conducted prior to approval.

We are concerned because some of these biologics, including dalteparin, ovine and bovine hyaluronidase, enoxaparin, verteporfin and bivalirudin are listed on the Department of Veterans Affairs National Drug Formulary and dispensed to disabled veterans through the VA healthcare system.

Our concern is compounded by the July 11, 2009 recommendations from the International Society on Thrombosis and Haemostasis (ISTH) regarding follow-on versions of low molecular weight heparins, which are currently used by VA to treat blood clots and deep vein thrombosis, and during certain surgeries.

The ISTH recommends thorough laboratory testing, human clinical trials, additional testing on patients with renal impairments, and head-to-head clinical trials involving the original biologic and any biosimilar. We believe this is the safe and correct approach to approving all follow-on biologics, yet some VA medicines could be exempt from these safety protocols.

We fully support the development of lower-cost generics and follow-on biologics to provide the best care for veterans using the broadest array of safe, effective drugs while keeping a lid on the cost to taxpayers. By closing this loophole and providing stringent clinical testing of all follow-on biologics, we place a higher priority on the safety and health of the many veterans who have served our country and now receive VA healthcare.


Lawmakers should go on public health plan

From M. Carabeth Benson

(Regarding July 23 articles “Senate Dems push healthcare to September,” “Pelosi backs off recess healthcare deadline,” and related coverage.) Go home for your vacation and read the healthcare bill that you will be voting on. What is good for us is good for you, so I support all of you having to use the same health plan as what you are going to give to us.

I heard the president say Wednesday night what a good health plan he has. I can imagine it is loaded for all of you, and you don’t have to worry about getting a doctor’s appointment or getting the medicines that a person needs.

I am against the government running my health plan. Why should my taxpayer dollars go to someone who is here illegally? And where are the jobs? If people could get a job they could afford whatever insurance they want.

Galesburg, Ill.

Bailed out, still lobbying

From Edwin E. Mack

(Regarding article “Autos, banks spend $20M lobbying,” July 22.) If our government is spending millions and millions of dollars to save these businesses through taxpayers’ money, how in hell can these companies spend $20 million lobbying? What part of our government is accepting these dollars from lobbyists?  … Our problems can’t be continuously blamed on the Republicans. They had their big-time screw-ups but the Democrats have had the run of the Congress, and if they used their power the way they should have, they would have overridden the Bush errors.

Port Byron, N.Y.