Congress has taken up the Obama administration’s goal of making healthcare more affordable by introducing various strategies for reducing the cost of prescription drugs. But the Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization (BIO) have resisted several of Congress’s initiatives, and cost control has been elusive so far.
Strong opposition can block legislation quite effectively, as Sen. John McCain (R-AZ) recently discovered. A Senate Committee defeated his amendment to allow the reimportation of prescription drugs when McCain tried to append it to the “Affordable Health Choices Act.” And the amendment was withdrawn from the “Family Smoking Prevention and Tobacco Control Act” before that.
Likewise, an approval pathway for follow-on biologics that does not contain 12 years of data exclusivity will face stiff opposition from BIO. Rep. Henry Waxman’s (D-CA) “Promoting Innovation and Access to Life-Saving Medicine Act” has faced criticism from Congress and industry alike. At first blush, you might predict its fate to be similar to that of McCain’s drug-reimportation amendment.
But, as Senior Editor Patricia Van Arnum noted, the White House has signaled its preference for an approach similar to Waxman’s. BIO called the approach a “risky short cut to biosimilars” and will undoubtedly be bending lawmakers’ ears about its preference. Nevertheless, the Presidential imprimatur could make a great difference. President Obama remains widely popular and might have enough political strength to draw the Congressional support he needs to codify his vision for follow-on biologics.