Monumental Reform Needed At FDA

By Rob Wright, Chief Editor, Life Science Leader
Follow Me On Twitter @RfwrightLSL

One of my favorite movies is “Oh Brother Where Art Thou.” The story takes place in the deep South in the 1930s. Campaigning Governor Pappy O’Daniel is lagging behind his opponent Homer Stokes, running on a platform of “Reform.” Junior O’Daniel tells Pappy, “Well people like that reform. Maybe we should get us some.” Fast-forward to present reality. President Obama said the FDA is not up to speed on current technology. As a result, he asserts that the organization is not able to handle current medical advances. “Their model was designed for the kind of medical devices you see in museums,” he said. Ouch. Before a panel meeting on jobs, Obama went on to recommend getting a group together to think about how to improve regulatory bodies to be more responsive in a dynamic economy. Sounds like reform.

In February, I attended the Conference Forum’s R&D Leadership Summit. At this event, leaders in the pharmaceutical and biotechnology industries, working as a “think tank,” met to discuss a variety of topics, including ways to improve the drug approval process. One of the panel discussions “Industry Point of View on How Safe is Safe Enough,” focused on the regulatory and safety hurdles regulatory agencies have put in place and how the industry should address them, so as to speed up innovation and remain economically viable. Recommendations for reforming the FDA were discussed. Unfortunately though, no one from the FDA was there to hear them. Not for a lack of trying as members of the FDA were invited.

For what their worth, here are my recommendations.

Let’s start with taking your head out of the sand. Tom Abrams, who heads up the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) suggested that the agency is thinking about making some small tweaks to current marketing rules rather than sweeping changes. The FDA does not want to issue “quickly outdated” guidance with regard to how companies can use social media. Perhaps they are concerned that social media companies like Twitter, Facebook, and Google are going to be out of business or not as important in the near future. Don’t get your hopes up. These three companies make up half of the top six most innovative companies as ranked by Fast Company in 2011. You can quote me on this — Social media will continue to grow in importance. One only need watch what is going on in the Middle East to realize this. Protestors have used various forms of social media to organize rallies and provide information to the outside world. The result has been sweeping changes in Egypt and soon to be in Libya.
Sweeping change to the FDA is what’s needed, not incremental innovation.

This leads to my second recommendation. When you say you are going to make a decision to provide guidance, take a tip from Nike and “Just Do It.” I published an article about FDA proposed changes to the supply chain in our February 2011 issue. The proposed changes were announced in the summer of 2010. As of this writing, specific guidance has yet to be released. Why? In my opinion, we have too many layer of bureaucracy at the FDA. The old saying “too many chefs spoil the soup” applies here. The FDA is understaffed, but it uses this as the excuse as to why there is a current backlog for approving generic drugs. The solution, have generic companies begin paying fees to get there products approved. The generic companies are lining up to do it. Not because it is right, but because some of the biggest brand name drugs in history are coming off patent. There is a lot of money to be made. So, if they pay a fee, the drug gets through the process more quickly. Sounds like a bribe, or a form of, to me. In the end, it’s the consumer who ends up paying more.

Big changes need to be made to the FDA. I know jobs are at risk. Having personally gone through a layoff, I know the pain. I don’t want to see anyone lose their job. But true reform needs to be monumental, not incremental. It won’t be easy and shouldn’t be. Anything worth doing well isn’t. We will see if the current administration is up to the task.