Time to stop playing games with generic drug approvals Posted by Earl Lui at 10/13/06 11:34 AM

“When is a citizen not exactly a citizen? When it’s a pharmaceutical company looking to increase its profits,” writes Consumers Union President Jim Guest in a column in the current issue of Consumers Reports. Jim’s column explains how brand-name drug companies interfere with the marketplace by unfairly blocking generic drugs from competing with the brand names.

The brand-name companies use many weapons to fight cheaper generic drugs. They can file so-called “citizen petitions” with the FDA to challenge the approval of a generic. Yet the overwhelming majority of such petitions filed from 2001-2005 failed to raise genuine issues. But these petitions accomplish their real goal: delaying FDA approval of generics. As the Washington Post reported:

Some at the FDA, as well as leaders in the generic drug industry, complain that "citizen petitions"--requests for agency action that any individual, group or company can file--are being misused by brand-name drug makers to stave off generic competition.

The simple act of filing a petition, they say, triggers another round of time-consuming and often redundant reviews of the generics by the FDA, which can take months or years. In the process, consumers continue to pay millions of dollars more for the brand-name drugs.

As bad as bogus “citizen” petitions are, it gets even worse: brand-companies actually pay off generic companies NOT to bring generics to market. Topping off this sad state of affairs: the FDA is so underfunded, it can’t even process all generic drug applications already in the pipeline. As of February, the Washington Post reported, a record 800 generic applications were waiting to be processed.

Congress needs to act now to get affordable generic drugs into marketplace more quickly. A bipartisan bill introduced earlier this year in the U.S. Senate would be a good first step.

comments (8)

1 Posted by christine at 11/01/06 11:51 AM

I am sure my father, who pays $3 per pill, will be happy to hear about these costly delays. He is 80 years old and has trouble making ends meet because of all of his prescription medications that do not have generic versions. He can barely keep up the work on his car and for what? So the big drug companies can be the 'fat cats'? Thank you to the inefficient federal government and the big drug cos.

2 Posted by Toni K. Burniston at 11/01/06 12:01 PM

On one occasion when I was taking the drug Varapamil for high blood pressure, I went to my HMO pharmacy to have my prescription refilled. They had run out of it and gave me a generic version of it. Within a day or two of taking it, I woke up about 3:30 in the morning with my heart pounding and my pulse racing. Even my face felt like it was pounding. I lay there wondering what the heck was going on as this had awakened me from a sound sleep. Then I got to thinking about the generic drug I had just begun to take. I suspected this was the source of this. I then remembered that I had a few of the original Verapamil tablets in a pill box which I carried in my purse. I got up and took one of them and within twenty minutes my heart quit pounding and my pulse returned to normal. The next morning I called the pharmacy and reported this. The pharmacist agreed that it was the generic drug which was responsible. Be careful what you take!

3 Posted by Wayne Ware at 11/01/06 03:10 PM

Unfortunately in today's world, it's all about money. Big Oil and Pharmaceutial Companies are the major contributors to the present political party in power. Their money talks and talks loudly to the politicians running our country. Of course they will go to all lengths to halt generic competetion to their grossly overpriced products. Who's to stop them?

4 Posted by Gary M. Poppas at 11/01/06 05:04 PM

While there are most likely a few generic drugs that fall below industry standards, the majority seem to be entirely adequate. Those which aren't "up to snuff" should,of course, be outlawed until a better,safer version is introduced. This responsibility falls squarely on the grossly underfunded FDA.Not only is it underfunded, but I think you will find it is controlled by those who
have reason to base their decisions on something other than what is best for the people who need
help the most.This and other government agencies
seem to be operated in such a way as to favor the large corporations that have such a large part of
policy-making duties. PLEASE remember to vote.

5 Posted by Rachel at 11/01/06 05:38 PM

My prescriptions cost more a month than I draw on disability. I can't get anyone to tell me I can get help, all they say is "we know it won't help everyone." That phrase came from 3 different calls and going over all my medications with Medicare. Each person told me a different story.

This year my "supplemental" insurance went up 25% and is now within $20 dollars of my of my house payment.

If I were running for office I would not let them say I agreed with the prescription plan.

The "donut hole" is just a way to steal money from the needy or let them die.

I have the plan that AARP, my Pharmacy, and Medicare recommended.

I have to spend over $4000 out of pocket before I get any decent coverage. I don't have $4000....I'm borrowing it. God bless the person that lets me borrow this money.

Oh yeah, when your insurance is paying nothing they still demand we make premium payments.

Something isn't right and we need a drastic change.

6 Posted by Mary S. at 11/01/06 08:19 PM

All of our family is on Zyrtec for asthma, esp
son who is adopted. State of Fla. will now only buy 14 pills per month for him, he takes one a
day to be mostly out of Asthma symptoms. Bal. of
bill for me for him alone is $51, and hubby and
my co pay per month is $50 each. Thanks to our pharmacy's urging, we went to Canada for it, and
pay less than $1 per pill, and they discount us
for referrals. Pharmacist stated they had generic
and they were legitimate, because Canada removed
copywrite on drug company.

We would obviously pay our son's
but we would do without if it weren't for Canadian drugs.

We would then be fighting the resulting broncitus
and pneumonia, we used to get as the result of
allergies.

One shipment got snagged by HOmeland security
(while the Mexicans were climbing over the fense)
but company resent at no cost our order.

Time to get serious and know we are safe.

7 Posted by Liz at 11/02/06 09:41 AM

Lots of Americans, like you Mary, buy their medications from Canada at much cheaper prices. Some have gotten their drugs confiscated, however.

This happened to Leona Tockey, a California senior whose heart medication was not allowed out of Canada after she bought it. . A California news channel ran this story about this: http://www.ktvu.com/video/9773868/index.html

8 Posted by Matt at 12/01/06 06:43 PM

I strongly suspect that if pharmaceutical companies put more money into actually curing diseases, instead of researching ways to keep people dependent on temporary fixes like daily pills, than the world would be a better place, but as it is, these are companies, which want to keep their customers buying.