1. More new drugs are being yanked well before they enter clinical trials. A good thing that can be chalked up to thinning revenues, higher standards, harder targets and better development tools.
2. The safety delta on all drugs is higher. Not a good sign. REMS and Safety First means approval times are slower or drugs are not approved on the first go round.
3. Clinical development is becoming more a legal battle and less a scientific one. If you don't believe me read this article from www.ft.com where the CEO of Watson Pharmaceuticals says generic lawsuits are causing drug companies to stop innovating. He calls it "eating their young." /tinyurl.com/259ko9q
4. Compared to previous years there are still fewer new drugs being introduced and those are being slowed down as these drugs are now considered less special or non priority. As Ed Silverman at Pharmalot notes:
"Overall, there was a 25 percent decline in first-cycle approval rates for priority-rated new drugs and a 17 percent decrease in priority designations for new drug applications, or NDAs. First-cycle reviews for priority NDAs were 47 percent in fiscal year 2003 and continued to climb to 70 percent in fiscal year 2007, but have since slipped back to 53 percent in fiscal year 2009."
Ed goes on to quote Paraxel consultants:
"As for priority designations for original NDAs, fiscal year 2005 marked a high of 30 percent after running as low as 10 percent four years earlier. However, that fell back to 13 percent in fiscal year 2009. Parexel says the decline has been “most stunning” in for antiviral and oncology NDAs, which are the two therapeutic areas that have driven overall rates at the FDA’s Center for Drug Evaluation and Research in previous years.
Priority designation rates for cancer NDAs have been declining consistently for several years, from 65 percent of the NDAs submitted between fiscal year 2003 and fiscal year 2005, to 18 percent in fiscal year 2009. The decline in AIDS and other antiviral therapies fell from 95 percent in fiscal year 2006 and fiscal year 2007 timeframe to just 8 percent among NDAs submitted in fiscal year 2009."
www.pharmalot.com/2010/10/the-fda-review-process-and-the-new-normal/
Is the bar being raised at the FDA for drugs that are truly innovative and targeted? It is not the FDA's business to determine whether one medication is better than another. Each treatment has to stand on it's own risks and benefits with respect to the people it treats.. But:
“The FDA’s 13 percent priority designation rate for 2009 new drug applications mirrors the low rate at which some health care plans and other payers are finding value in newly approved drugs. This illustrates the need for companies to take into account market-based clinical concerns in the product development process market-based clinical concerns in the product development process,” according to Charles A. Stevens, Vice President and General Manager, Reimbursement and Market Access, PAREXEL Consulting."
tinyurl.com/32ycdww
The question is whether the clinical development process is the appropriate mechanism to taking these concerns into account or whether it comes at the cost of true value. And innovation.
