The FDA picks winners and losers. Winners are almost always big pharma. Losers are almost always small entrepreneurial and first timer companies.

Nassim Taleb dressed me down once in a public situation (when discussing his new book at the time, "Anti-Fragile." where I claimed that businesses are always better than government, because all business have the potential to add to the economy whereas governments do not. He called me out and said that large companies were no better than the the government. He turned out to be right. Large companies are all looking for a handout, they all solicit government to protect their turf, they all have their stable of lobbyists and they will all take any opportunity to snuff out a free market. The FDA helps in this effort.