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In the Absence of Vicodin and Percocet, Other Options Would Remain

July 12, 2009

Analysis of:Doctors say an FDA ban on Vicodin and Percocet would limit their treatment options | www.palmbeachpost.com

O  The physicians quoted in this article appear not to know what other analgesic drug formulations are available -- including Vicoprofen (hydrocodone plus ibuprofen), codeine (both alone and in combinations), oxycodone, etc. O  Many patients would benefit from a ban on Vicodin and Percocet, at very little cost in convenience.

Another way to promote R&D: More scientific and reasonable regulation

May 1, 2009

Analysis of:Obama promises major investment in R&D | finance.yahoo.com

(1) A robust science and technology enterprise is the engine that drives economic recoveries. (2) Many Obama administration senior officials have a dismal history of anti-science, anti-technology ideology; they are ill-equipped to advise and make policy.

FDA's Escalating Risk-Aversion

December 15, 2008

Analysis of:FDA Panel To Weigh Heart Trials For Diabetes Meds | www.pharmalot.com

FDA continues to become increasingly risk-averse, lengthening drug development times and causing R&D costs to soar.  The huge new infusion of appropriated funds for the next federal fiscal year -- an additional $500 million -- will ensure more of the same.

A Finding for Levine Could Endanger Your Health

November 18, 2008

Analysis of:FULL DISCLOSURE: DRUG REACTION | www.callawyer.com

FDA warnings on drug labels should not be viewed as "minimums" but as "optimums" that can be revised only through further FDA actions.  Were the Supreme Court to find otherwise, the pharmaceutical industry could be severely damaged.

CBO Estimates About Savings From Follow-On Biologics Are (Necessarily) Very Crude -- and Probably Overly Optimistic

July 1, 2008

Analysis of:Follow-On Biologics Legislation Could Save Billions of Dollars, According to CBO | www.kaisernetwork.org

There any many imponderables in the CBO estimates, including the period of marketing exclusivity (if any) granted by not-yet-passed legislation and the extent to which the FDA requires new clinical trials for follow-on biologics.  I would argue, therefore, that their predictions are premature.

More Hot Air Than Hot Products

June 9, 2008

Analysis of:Novartis presents full pipeline of novel vaccines addressing significant unmet needs | www.pipelinereview.com

Novartis' rhetoric seems not to be supported by the published data.  Novartis probably lags behind Merck and Sanofi-Pasteur in vaccine R&D.

Worse Than Just Wasting Resources, Wrong-Headed UN policies Exacerbate Global Warming

May 28, 2008

Analysis of:Billions wasted on UN climate programme | www.guardian.co.uk

The UN's anti-science, anti-technology policies exacerbate global warming and water shortages.  The poorest of the poor are most affected.

Both the FDA and Its Congressional Oversight Are Broken, With Little Hope of Repair

May 27, 2008

Analysis of:Lawmakers Call On Companies to Curb Dug Ads | news.yahoo.com

The FDA is poorly managed and overly risk averse, resulting in skyrocketing drug development costs and fewer approvals.  Congressional oversight, increasingly negatively disposed toward the pharmaceutical industry, is a stimulus to this trend.

Drug Counterfeiting: The Invisble Crisis (for Companies and Consumers)

April 23, 2008

Analysis of:U.S. Identifies Tainted Heparin in 11 Countries | www.nytimes.com

The counterfeiting of drugs -- which encompasses not only products that are completely fake, but also those that have been tampered with, contaminated, diluted, repackaged or mislabelled in a way that misrepresents the contents, dosage, origin or expiration date -- is a huge and growing problem.  It imposes huge costs, both monetary and in lives.  Governments and individuals must make the detection and combating of counterfeiting a high priority.

The Risky Business of Regulating Risk

April 22, 2008

Analysis of:Political Pendulum Swings Toward Stricter Regulation | online.wsj.com

More regulation is not synonymous with greater safety or enhanced benefits to society.  Often, the opposite is true because excessive regulation is a drag on innovation, diminishing competition and the number of products available to consumers, and inflating prices.  Instead of overreacting to acknowledged failures of oversight, Congress and federal regulatory agencies should consider carefully how we can better approximate the ideals of finding the amount of regulation that is necessary and sufficient for a given product, process or activity, and of imposing costs that are commensurate with the societal benefits.

"Preemption" Removes Double Jeopardy, Protects Innovation

April 21, 2008

Analysis of:The Dangers in Pre-emption | www.nytimes.com

The combination of a huge regulatory burden plus the uncertainty and the vast costs related to product liability threatens innovation.  "Preemption" -- the presumption that drugmakers are not culpable for mishaps with their drugs, as long as they have fully satified federal regulators -- removes double jeopardy and makes sense.

NY Times Editorial Misunderstands, Misrepresents Pharmaceutical Development

April 16, 2008

Analysis of:When Drug Costs Soar Beyond Reach | www.nytimes.com

The cost of certain drugs is high -- but so are the regulatory costs and the financial risks of drug development.  The process is overseen by the FDA, whose increasing risk-aversion continues to make drug development more expensive and uncertain.

Not A Big Deal for Glaxo

April 14, 2008

Analysis of:FDA: Glaxo Failed To Report Avandia Studies | www.pharmalot.com

The infractions cited by the FDA are minor, and the Warning Letter is anything but "harsh."  The implications for Glaxo are likely to be nil, with the exception that the Warning Letter will be used by plaintiffs' attorneys in Avandia-related litigation.

Real F.D.A. Reform Remains Elusive, Current Negative Trends Are Likely to Continue

April 14, 2008

Analysis of:It's Time to Reform the F.D.A. | www.nytimes.com

The F.D.A. is the nation's most ubiquitous regulatory agency, a "gatekeeper" whose approval is required before drugs, biologics and medical devices can be marketed.  Trends are worrisome -- greater risk-aversion from F.D.A. officals, skyrocketing development costs, fewer drugs approved -- and getting worse.  No relief is in sight.

Patients and Drug Companies Are Dying for F.D.A. Reform

April 11, 2008

Analysis of:It's Time to Reform the F.D.A. | www.nytimes.com

The F.D.A. is the nation's most ubiquitous regulatory agency; every American encounters F.D.A.-regulated products many times every day.  Fulfilling a "gatekeeper" function -- which means that regulators must approve drugs, biologics and medical devices before they can be marketed -- the agency's policies and performance exert a profound impact on innovation.  As drug regulators have raised the bar for approval and become progressively more risk-averse in recent years, drug development costs have skyrocketed and pipelines have dried up.

Biosimilars (also known as biogenerics, generic versions of biological drugs) are coming -- and science must show the way to regulate them

April 11, 2008

Analysis of:Neutropenia: Biosimilar Product from India Moves One Step Closer to European Market | www.pipelinereview.com

O  "Biosimilars," or generic versions of biological drugs, are possible -- and are coming -- but scientific considerations must dictate the extent and kind of testing that is required, and the criteria for approval by regulators.  O  The drug described in the source article is less a generic version of a biological than it is a new and distinct drug -- because it is undergoing safety and efficacy testing instead of the merely the pharmacokinetics testing that usually is considered sufficient for a generic version of a small-molecule drug.  O  The testing of this product illustrates why "follow-on drug" might be a more apt description than "biosimilar" or "biogeneric." O  Regulators (and the company that makes the follow-on drug in the source article) seem to be adopting a conservative approach -- performing the amount of testing that is necessary, even if it is far more than is usually required for a conventional generic version of a small-molecule drug.

Government regulation of consumer products: Sometimes, less is more.

April 11, 2008

Analysis of:Political Pendulum Swings Toward Stricter Regulation | online.wsj.com

(1) There is an inverse relationship between the stringency of regulation and innovation.  (2) We should seek to impose the amount of regulatory scrutiny that is necessary and sufficient to ensure environmental and public health.  (3) Regulation must be cost-effective.  Often, it isn't.  (4)  Many members of Congress appears to believe in the notion that more regulation always makes us safer.  They're wrong.

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