Tufts Optimistic about Drug Development

In its Outlook 2007 report on pharmaceutical and biotech development, the Tufts Center for the Study of Drug Development (CSDD) says drug developers should be optimistic despite a growing list of development challenges including rising R&D costs, increasing regulatory stringency, and mounting public hostility over safety, and end-user costs.

Contributing to that optimism, Tufts CSDD (Boston, MA, csdd.tufts.edu) said, is greater use of new technologies to reduce late-stage development failures and contain rising costs, increased reliance on global outsourcing to speed development and reduce costs, and more coordination between US and European regulators.

As evidence that the industry has improved its R&D productivity, the report notes that the number of new drugs entering clinical trials by the top 10 firms increased by 52% over the first part of this decade. Also, small- and mid-sized pharmaceutical and biotech companies are increasingly filling the gap experienced by big pharma.

Other near-term trends cited in the Tufts report include:

• The high cost and low success rates of human studies will lead small- and mid-size companies to adopt outsourcing and other clinical practices that big pharma increasingly uses to control costs and manage risk.

• Biotech firms will escalate biodefense and pandemic disease related R&D.

• Within two to three years, up to 65% of FDA-regulated clinical trials for top pharmaceutical companies will be conducted abroad.

• The European Medicines Agency (EMEA) will focus on implementing new legislation and integrating drug regulatory agencies of new European Union members into a comprehensive pan-European system.

• US third-party payers will move away from a binary coverage model in which prescription drugs are either covered or not covered. Instead, more than 90% of prescription drugs will be covered with a variety of limits.

European Approvals Lag US

In another recent report, Tufts CSDD revealed that many medicines become available in the US before the European Union, even though the EU has met mandated performance goals for review times for new drugs. The study found that mean approval times for new products approved in both the EU and the US during 2000–2005 were nearly identical: 15.8 months for products approved by the EMEA and 15.7 months for those approved by the FDA.

According to the study, the recently enacted EMEA regulations- conditional marketing authorization and accelerated assessments, which parallel existing FDA initiatives-enabled the agency to meet, or come close to meeting, its performance timeline goals for all product categories for each approval stage. The study also shows that for 71 products receiving both FDA and EMEA approval, the FDA acted faster than the EMEA in 47 of the cases.

The study also noted that although the FDA approved a greater number of products faster than the EMEA during 2000–2005, there was greater variability in FDA approval review times. Also, regulatory designation does not appear to have as much impact in the EMEA as in the US, as exceptional circumstance approvals are, on average, only 1.5 months faster than non-exceptional approvals. Approval times for orphan products in the EU and the US were nearly identical to those for non-orphan products in the same region.