Most New Drugs Are Me-Too Medications
Nearly two-thirds of
prescription drugs approved in the 1990s were modified versions of existing
drugs or products containing the same active ingredients as those already on
the market, according to a new study by the National Institute for Health
Care Management (NIHCM) Foundation.
Only 15% of new drug approvals
were for medications that contain new active ingredients and provide
significant improvement over existing drug therapies, the study found.
The findings strike at the
heart of the pharmaceutical industry's claim that changes to Hatch-Waxman,
the 1984 US patent protection law, would harm patients by stifling drug
innovation. It is because of these protections, the foundation argues, that
drug companies seek to extend their market exclusivity by introducing
altered versions of older medications.
It's very hard to come up with
very innovative drugs. So when drugmakers get a successful product, they
need to protect it by modifying it in some way.
 Intellectual property
protections are intended to foster real innovation, "but what we've done is
created a great deal of incentive to tweak the product. What we see here is
that the drug companies are protecting their brand franchise.
The NIHCM Foundation study is
based on US Food and Drug Administration (FDA) statistics on new drug
applications (NDAs) approved from 1989 to 2000. It incorporates the agency's
own system of classifying those applications based on a drug's level of
innovation.
Of the 1,035 drugs approved by
the FDA over the 12-year period, only one-third (361) were new molecular
entities, which treat diseases in novel ways, the investigators found. Less
than half (153) of those were given "priority" status, which is reserved for
drugs the agency believes could provide significant clinical improvement
over existing medications. Of the 674 drugs that didn't contain a new
chemical entity, only 91 were given priority status.
Among the highly innovative
drugs that were approved were Pfizer Inc.'s Lipitor (atorvastatin) for high
cholesterol and Viagra (sildenafil) for erectile dysfunction, as well as
Merck & Co.'s Fosamax (alendronate sodium) for osteoporosis; and
GlaxoSmithKline's Avandia (rosiglitazone) for type 2 diabetes.
But a total of 674 drugs, or
65% of FDA-approved medications, contained active ingredients that were
already available in marketed products. Of these, 558 drugs differed from
the marketed products in that they were combined with another active
ingredient, offered in a different dosage form or delivered through a
different route of administration.
A product traditionally
available in oral form, for example, might have been reformulated to be
delivered via a transdermal patch.
Retail spending on prescription drugs doubled from $64.6 billion in 1995 to
$132 billion in 2000.
Of the $67.4 billion increase,
$44 billion is the result of increased spending on drugs approved between
1995 and 2000. Priority drugs with new chemical ingredients accounted for
33% of the increase in spending. "Standard-rated" drugs, which don't qualify
for expedited FDA review, accounted for 67% of the increase.
New drugs of all types were
priced much higher than the older drugs they replaced, the study notes. New
priority-rated drugs commanded the highest prices. In 2000, the average
price per prescription for the most innovative class of drugs was $91.20,
versus an average price of $37.20 for older drugs, approved before 1995.
At $65.07 per prescription,
incrementally modified drugs designated for standard review, while not as
expensive as some other classes, still cost 75% more than older drugs in
2000, the researchers found. This suggests that brand manufacturers can
maintain relatively high prices for aging products by making incremental
changes to them.
The point is that a lot more
money is going into prescription drugs, but it isn't producing many more
innovative medicines. Increased spending may help to support research and
development, "but what it also definitely does is support a lot of line
extensions" to help preserve blockbuster products.
National Institute for Health
Care Management (NIHCM) Foundation May 28, 2002
This report, although
published recently, does not have the more current statistics which show
$175 billion was spent on drugs in 2001, up from the $132 billion in 2000.
This easily translates to $200 billion dollars for drugs in 2002.
It is a sad, but not totally
unexpected tragedy, that the country's drug use is being extended to our
children. Americans had more than 3 billion prescriptions
filled
last year.
On average that is one
prescription, every single month, for each man woman and child in the US.
As the late Illinois
Senator, Everett Dirksen was fond of saying when he was referring to the
Defense Department budget, "a billion dollars here, a billion dollars there
and before you know it, you are talking real money".
Well we are talking a lot
more than a few billion dollars. How about something like a nearly 200
billion dollars for drugs spent last year.
The sad tragedy is that we
are spending all of this money on disease management focused on drugs and
our return on this investment is profoundly poor.
Clearly there is something
seriously wrong here.
For further comment on this
article please see
Nick
Regush's analysis.
Related Articles:
Health
Spending Growing Faster Than US Economy
Pharmaceutical Spending Continues Steady Increase
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