Comments on: Drugmakers Threaten To Oppose Health Bill

By: pharmavet

pharmavet — Tue, 19 Jan 2010 15:57:00 +0000

Pfizer and Merck up almost 2.5% today (11AM) on anticipated demise of health care bill based upon expected results in Massachusetts senatorial election.

By: DSM

DSM — Tue, 19 Jan 2010 14:26:19 +0000

Condor, your comment about the differences between biologics and small molecules regarding patents was true five years ago, is still more or less true in America but not in Europe (where bioequivalent products are becoming common soon after patent expiration) and is unlikely to be true anywhere within a few years.

In any case, if trade secrets were that important, then the 12 year exclusivity rule would have no impact whatsoever.

By: Condor

Condor — Mon, 18 Jan 2010 23:33:58 +0000

DSM writes “There’s a lot of misunderstanding in this thread. Let me focus on the 12 year exclusivity: It actually is supposed to help fix a problem in the system. . . .”

Not the least of which is apparently DSM’s own misunderstanding.

Biologics differ from “old-line” chemical compound drugs in a number of ways — not least of which is that patents are far less important, as a barrier to competitor-entry (the manufacture of biologics is rife with trade-secret know-how, i.e., not easily duplicated by competitors — decidedly unlike powder-compound pill-making methods).

The current snit Tauzin is throwing applies only to biologics. It is highly-likely that the only “problem in the system” (to echo DSM’s turn-of-phrase) is that pharma wants more monopoly power ovr biologics — in the form of longer exclusivity.

That is all.

Namaste, one and all.

By: Robert

Robert — Mon, 18 Jan 2010 22:59:47 +0000

Drugmakers will oppose any bill that interferes with their ability to make a profit. That’s how business works. Corporations exist to make profit–that’s all. If the new health bill goes against that, they will fight tooth and nail to shoot it down before it reaches Obama’s desk.

By: Justice in MI

Justice in MI — Mon, 18 Jan 2010 21:51:27 +0000

We have all heard the argument that U.S. drug prices are necessary to sustain new drug development, etc. I would like to see any documentation that the _extent_ of ROI has, indeed, fired up R&D.

Not long ago, the guy who has head of Pfizer in Michigan said publicly that this claim was false. Pricing is based on value of the product, not R&D needs.

By: JAB

JAB — Mon, 18 Jan 2010 19:11:50 +0000

I visited walmart this weekend and found a list of over 400 generic Rx meds that cost $4 per month. I had two Rxs filled with these generic meds (Blood Pressure & Cholesterol). The cost for me was $8 for the 2 Rxs for the full month. These meds use to cost me $70-$100 per month each before generic. I feel rich today!!!! Then I wondered who would invest in R&D for new meds if Gov. takes away the incentive from Pharma? New innovative generics will never be developed? I thought our system seems pretty good. Invest now, get cheap meds after patent? Not bad quid pro quo for society…. Goverment seems short sighted?

By: gpawelski

gpawelski — Mon, 18 Jan 2010 18:43:26 +0000

The FDA does not allow all potential cancer treatments to reach the market, only those that they approve after a drug company invests an estimated $500 million to take the treatment through clinical trials. Drug companies will only invest this much money in treatments they can patent. The patent allows the pharmaceutical company to control the product, set the price, and make a profit.

By: DSM

DSM — Mon, 18 Jan 2010 15:56:49 +0000

There’s a lot of misunderstanding in this thread. Let me focus on the 12 year exclusivity: It actually is supposed to help fix a problem in the system.

Patents provide 20 years of protection from filing. Waxman’s previous bill (Hatch-Waxman, 1984) gives up to 14 years of exclusivity from launch of a new drug, recognizing that it takes a lot more time and effort to get to a drug to market than most other industries.

When does the 12 year exclusivity matter? When a drug takes a particularly long time to develop, which often means that it’s very novel… Me-too drugs are much faster to market. So think about what you’re incenting if you’re against the 12 year exclusivity.

By: patrons99

patrons99 — Sun, 17 Jan 2010 19:31:29 +0000

Oops! …no MORE acutely toxic… Sorry!

By: patrons99

patrons99 — Sun, 17 Jan 2010 19:27:02 +0000

Very inciteful, gpawelski. A shift toward biotech from chemistry-based drug development, requires a much lower burder of proof to gain expedited market approvals with the Non-inferiority margin as the choice of control. Pharma need now only show that their new biological is no less acutely toxic than those biologicals already out there, e.g. prevnar-13.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM190736.pdf