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The Atlantic has a very interesting article looking at the future of the Pharma industry. With most of the patents set to expire at the end of next year, many companies are also facing pipelines with few products and low approval rates from the FDA. With the clinical trials being the most expensive parts medical development, in addition to the targets of new drugs being very small portions of the population, many drugs are shelved or are out of financial reach for many of the patients who need to use them.
Pharmaceutical companies are blamed for focusing on marketing at the expense of innovation: they allegedly kill promising compounds because of fears of small markets, then concentrate on “me too” drugs that aren’t really any better than their competition’s. Or they tweak existing drugs in ways that don’t necessarily make the drugs any more effective, but do give companies a new patented drug for which they can charge the Earth.
Josef Bossart, PhD Managing Director BioNumbers LLC (Moderator)
Are we going for more difficult products, or are there more rookies in the game? The time for drug approval has significantly increased. DDEP has increased steadily over the years. The FDA is not the problem when it comes to approval times. The median average is about eleven months for FDA approval. If the data is poor, the FDA will send you back. The FDA is not the problem in drug delivery approvals. If you’re a drug development company, you should have 4-6 products in the pipeline in order to get one approved.
Many companies believe that $15 million to the MDA submission. There are $228 million dollars to get products developed in the early 1990s. Now that coast for DDEP is about $85 millions. The direct cost when risk is adjusted is $160 millions.
Key numbers: Data Points – In a study of drug development, Bossart found that one in six Pharma products that start in the market get approved.
There are a total of 197 DDEP have been approved in the period of 2000-2009, an average of 20 per year. The top year for approvals was 2007 with 28 DDEP approved by the FDA.
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