Word: generic
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...Generic Nudge The question before Waxman's committee last summer was this: How many years of monopoly protection should be afforded to biotechnology drugs, known as biologics, before cheaper alternatives are allowed on the market? These miraculous drugs - which differ from traditional, chemical-based pharmaceuticals because they are derived from living matter - are widely regarded as the future of the pharmaceutical industry and, indeed, of medicine itself. While only 20% of drugs on the market today are biologics, it is expected that, with 633 biotechnology medicines in development last year for more than 100 diseases, half the new drugs approved...
...policymakers look for ways to control health-care costs, the price of biologics is drawing more and more scrutiny. The obvious model for bringing in competition is a 1984 law that Waxman wrote with Republican Senator Orrin Hatch. It lowered the regulatory obstacles that prevented generic drugs from making their way to market. At the time, it was expected that fast-tracking the approval of "bioequivalent" drugs would bring down medical costs by $1 billion a year. But with generics now accounting for more than 70% of prescriptions dispensed in the U.S., "the actual savings have exceeded our wildest expectations...
...similar approach work with biotechnology drugs, which were not dealt with in the 1984 law because the industry was then in its infancy? A 2008 analysis by former Clinton Administration official Robert Shapiro, who has consulted for both biologics companies and their would-be generic competitors, suggested that generic versions of the top 12 categories of biologics whose patents have expired or will expire soon could save Americans up to $108 billion in the first 10 years and as much as $378 billion over two decades. "It's the low-hanging fruit," says Mark Merritt, head of the Pharmaceutical Care...
...problem. The U.S. and Britain have special police units to deal with falsified medication, but most other countries lag behind, Franquet says. Kubic says that political efforts to fight the problem have flagged in recent years, mainly because countries like India and Brazil fear that the large amounts of generic drugs they produce legally may be mistakenly targeted in a global crackdown on fake-drug-trafficking. (Read "Are Direct-to-Consumer Drug Ads Doomed...
Saturday’s events began with a speech from Dr. Matthew Craven, co-founder of Support for International Change, who focused on the importance of removing hurdles to wider production and distribution of generic drugs. Craven keyed on issues with “innovation, access[ibility] and delivery” of medicine to developing countries and argued that encouraging pharmaceutical companies to allow for the production of generic drugs was a step in the right direction in overcoming these challenges...