This Guy Just Raised The Cost Of An HIV Drug By 5000%

[Benton]

(09-22-2015, 04:33 PM)Nebuchadnezzar Wrote: I don't know what REMS means, but I think I get the idea.

Can a different drug company now develop their own drug that does the same thing though?

The drug has been out long enough, I don't understand why a different drug company can't develop their own drug. It takes a while to get a drug approved, I know and a company might not want to waste resources and money developing something that won't make a decent profit.

I'm wondering if this company raised the price of this drug to lure competitors to waste time, resources and money developing their own drug then when this other company is about to release the drug, the first company drops the price below what the second company has to price theirs at.

I don't know, that scenerio seems kind of a waste, but I'm a cynic and I don't trust anyone with anything at any time, lol.

Risk Evaluation Mitigation Strategy. It's an FDA hoop for drugs that can be very beneficial but have significant side effects. Like growing hair on your eyes. Or dying.

And like any good company with a squad of attorneys, drug companies have found ways to keep generics from gaining access through the Hatch-Waxman Act by using REMS.

http://healthaffairs.org/blog/2015/03/24/ensuring-timely-approval-of-generic-drugs/

Quote:Unfortunately, there has been a growing trend in the pharmaceutical market of brand-name manufacturers actively seeking to prevent generic manufacturers from getting their hands on these samples and information. For example, some brand-name manufacturers have taken advantage of risk evaluation and mitigation strategies (REMS), a relatively new post-approval requirement that the FDA can impose on drugs with known or potential toxic side effects. REMS components can range from medication guides and communication plans, which aim to educate patients and providers, respectively, to more complex “elements to assure safe use.”

Many drugs subject to this more complex REMS component cannot be purchased in the standard way; rather, they must be distributed by specially-certified prescribers and pharmacists, may have limits on the amount of drug dispensed, and can include mandatory enrollment and monitoring of patients within registries. Brand-name manufacturers have argued that they cannot provide generic manufacturers with samples of such REMS-covered products necessary to conduct the FDA-required bioequivalency testing because doing so would be outside the restricted distribution pathway.
Other brand-name manufacturers have even patented their REMS as new and useful methods of conducting business, artificially extending the market exclusivity period of their products. Celgene, for example, patented its REMS for thalidomide (Thalomid), an old drug now used to treat multiple myeloma (a form of cancer) but that also causes birth defects. The patent for the active ingredient of thalidomide expired decades earlier.

...

Matrix Global Advisors estimates that anti-competitive uses of REMS result in a staggering $5.4 billion in lost savings annually from the delayed market entry of generic drugs.