Reverse Payments in Generic Drug Settlements - Part IV
03.03.10
Plaintiffs fell into
three groups: (1) the "State Law Plaintiffs," indirect purchasers,
and class representatives, from various states (California, Michigan,
Minnesota, New York, North Carolina, Tennessee, and Wisconsin and the District
of Columbia) whose complaints, initially filed in state court and then removed
to federal district court by defendants, allege violations of state antitrust
and consumer protection statutes; (2) the "Sherman Act Class Plaintiffs,"
direct purchasers, and class representatives, whose complaint, filed in federal
district court, alleges a violation of federal antitrust law; and (3) the "Individual
Sherman Act Plaintiffs," two groups of purchasers, not representatives of
any class, whose complaints, filed in federal district court, allege violations
of federal antitrust law (filed by The Kroger Co., Albertson's, Inc., The Stop
and Shop Supermarket Co., and Eckerd Corp.); JA 887-896 (filed by CVS Meridian,
Inc. and
Source: Patent Docs (blog)
The FDA Puts 27 Drugs on Watch List: Is Yours One?
22.02.10
It is the job of the US Food and Drug Administration (FDA) to review each and every medication initially put on the market, and then monitors it over the progressive months and years. They do this with the help of Adverse Event Reporting System (AERS) which is an online site anyone can review and submit information to.
Based on this information, the FDA creates a to-watch list and for 2010, 27 medications have landed there. The FDA is very clear that the list is to evaluate potential concerns and is not a guaranteed removal from the market nor does it want healthcare providers to stop prescribing or consumers to stop taking these medications (unless, of course, you are experiencing the side effects).
For a full view of the list, you can visit www.medscape.com/viewarticle/717321 , or visit the website for the FDA at www.fda.gov . I want to point out a few that I see many patients using on a regular basis.
Gabapentin (neurontin), a pain medication, is under FDA review for drug reaction with eosinophilia and systemic symptoms which includes high fever, rash and inflammation of one or more organs that can be severe.
Source: EmpowHer (blog)
Reverse Payments in Generic Drug Settlements - Part III
26.02.10
Dear EG:
I know there are lots of ways such agreements can have anticompetitive effects that overweigh the procompetitive effects, but the FTC takes a per se approach - a lot like the anti-gene patenting crowd. "It's just wrong" is rarely a coherent answer. I am doing these comparisons to tease out why the different Circuit Courts of Appeal (not just the CAFC) have assessed these individual agreements and come to the conclusion that they are not illegal.
The next post, on the Cardiozem case, is different, as the CAFC noted - different scope, different effects, etc. But that's the point - per se isn't an answer, it's a policy and a very blunt tool at that. Added to the deficiencies of the approach is the study we posted on a few months ago, that on the basis of economic efficiency the Hatch-Waxman provisions of Sec. 271(e)(2) are not as beneficial as advertised.
I don't blame the FTC - they are economists (a severe burden) and they are outcome-oriented. Bad combination, especially since they have not evinced an understanding (or desire to understand) patent law. If we ran the experiment without reverse payments, we would have a mixture of consequences - some branded pharma patents would be invalidated, some would not, some generics would come on the market faster, some would not. Whether this was a good or bad outcome would depend on the drugs that became generics and perhaps whether the decision maker used those drugs. But for the system as a whole, the question is resources - legal, investment, etc. Would there be more or less litigation? Would it drain more or less resources (both for branded and generic drugs) from other uses of capital? Would it inhibit investment because of increased risk? Economists can model this, but I'm not sure the FTC has - I think all their modeling has been on the back end, on the
Source: Patent Docs (blog)
The company also received the FDA's approval for its abbreviated new drug application for generic Cardizem LA product indicated for the treatment of