The U.S. Senate is working on legislation to revise and extend prescription drug user fees (S.3187, the “FDA Safety and Innovation Act”), but various amendments are being offered that would undermine the “safety and innovation” features of the bill. An amendment to allow for the importation of prescription drugs, for example, would put the lives of American consumers at risk. Importation also threatens innovation and investment in the dynamic and entrepreneurial U.S. pharmaceutical sector where many small firms operate and compete on a global scale.
There is nothing safe or pro-innovation about drug importation, and that is why the U.S. Senate must reject the amendment sponsored by John McCain (R-AZ). SBE Council has consistently expressed our opposition to importation over the years, and thankfully Congress has consistently voted down multiple attempts to allow for the importation of foreign drugs into our markets.
For one, various media and government reports have found that importation increases risks regarding counterfeit or mislabeled medicines. These drugs may be potentially unsafe -- even deadly. Rogue websites do not require valid prescriptions, and a significant portion sell foreign or non-FDA approved medicines.
From a competitive perspective, importation effectively means importing price controls from other nations. Pharmacies, including small mom-and-pop shops, would face losing customers or even being forced out of business due to foreign governments' setting prices, and Congress allowing those misguided policies to be imported into the U.S.
But the greatest damage would be done to pharmaceutical firms. One of the key reasons why the U.S. has the most innovative pharmaceutical industry in the world is for the simple reason that we do not impose price controls. Limiting prices means limiting potential returns. That, of course, discourages investment, research and innovation.
The pharmaceutical business involves substantial risk taking. It costs as much as a $1 billion and 10-15 years to bring a drug to market, and for every 5 to 10 thousand compounds tested, only one medicine makes it to the marketplace. And, most pharmaceutical firms are small to medium-size companies - with 90% of manufacturers having fewer than 500 employees, and 56% fewer than 20 employees. That's small business.
Pharmaceutical firms are working on the medicines that will improve and save lives. Imposing - or importing - price controls places this incredibly important work in peril.
We hope the Senate votes for common sense, and votes down the McCain Amendment to allow for importation, which places lives and an important U.S. industry in danger.
Karen Kerrigan, President & CEO