Three Ways Congress Could Help Save Lives

Since the Democrats regained the House and the Senate, there have been many news articles posing the ways that Democrats and Congress could damage the pharmaceutical industry. The list of talking points includes potential legislative changes in Medicare and Medicaid, drug importation, drug safety and DTC advertising.

The articles cry foul play and set the stage for a battle between the Dems and Big Pharma to play their traditional roles.

Isn't time for change? Haven't we all heard that the healthcare system as it exists today is unsustainable and ultimately bankrupt? Haven't we seen the polls that rank the pharmaceutical industry alongside the oil companies in public opinion? Don't we all have personal stories about a healthcare system run amok?

If that doesn't move you, how about the fact that 70% of all clinical trials are delayed because patients are either uninformed or too distrusting of the industry to participate. Drug development costs for one approved drug are estimated at $802 million and climbing but we are testing the drugs on only 10% of the eligible patient population. Meanwhile, the impact of serious adverse events after approval eviscerates stock prices and leads to deepening rifts between patients and the pharmaceutical industry. Does this equation seems a little unbalanced?

Consider the positive impact legislative reform might bring:
Change: Implement patient education programs to replace DTC for the first 2 years post-approval.
Impact: A better informed, engaged and trusting patient population. Faster growth of preventative and personalized medicine.
Change: Require transparency and broad distribution of clinical trial results.
Impact: Improved cooperation and collaboration with patient advocacy groups, increased patient participation, greater speed to market, increased trust.
Change: Increase funding and support for FDA to integrate processes and improve resources.
Impact: The FDA becomes a place were the balance of good science and public safety is free of political influence and staff are rewarded not demoralized.

These are just three ways Congress can help save lives if we are open to change. To hear more on FDA reform listen to the Senate Committee on Health, Education, Labor, and Pensions: Full Committee Hearing Hearing - Hearing on Building a 21st Century FDA: Proposals to Improve Drug Safety and Innovation.