Brand-name drugmakers must have seen January as the 100 Hours from Hell. Generic drugmakers, on the other hand, probably heard angelic choirs. "It's safe to say that you can expect different outcomes in Congress under the Democrats," said Anna Schwamlein Howard, senior legislative representative for AARP. "You will see a lot of things being taken up and moving during this Congress that were never addressed under the last Congress."
Democrats campaigned hard on health care in the November 2006 Congressional elections, Howard noted. When victorious Democrats assembled for the 110th Congress, health care loomed large on the agenda. Rep. Nancy Pelosi (D, Calif.), the first Democratic Speaker of the House since 1995, promised a legislative whirlwind. She delivered. In health care alone, new bills would:
New legislation is only the beginning, noted Kathleen Jaeger, president/CEO of the Generic Pharmaceutical Association. Speaking at the Windhover FDA/Centers for Medicare & Medicaid Services Summit in December, Jaeger noted that Congress must also vote on the Prescription Drug User Fee Act (PDUFA), the Pediatric Research Equity Act, the Best Pharmaceuticals for Children Act, and the U.S. Trade Promotion Authority Act.
"It's a whole new ball game now," said Henry Simmons, M.D., president/CEO of the National Coalition on Health Care. "Democratic and Republican leaders have subscribed to the idea of moving to generic drugs whenever and wherever possible and making them more available."
The long march ahead
Introducing legislation is relatively easy. Getting bills passed is harder. And getting bills signed into law is harder still. That's one reason GPhA is talking softly about the new Congress. "There is growing momentum for legislation that would bring generics to consumers in a more timely fashion," said GPhA spokeswoman Andrea Hofelich. "It will be a busy year for us, but we aren't making any predictions or assumptions."
The American Pharmacists Association is also trying to restrain expectations. Catherine Polley, R.Ph., APhA's chief policy officer and senior VP for government and professional affairs, noted that Democrats have been vocal about making it easier for generics to get to market. Generics offer a workable way to increase access to affordable prescription drugs. But Democrats do not have a free hand. Despite all the talk of "fixing" Medicare Part D, Polley said it is unlikely that the Administration will allow any significant structural changes. That leaves Democrats trying to tinker around the edges, perhaps eliminating the late sign-up fee or shrinking the coverage gap.
For now, Democratic leaders are still exploring the possibilities of power. That's the story behind H.R. 4 (John Dingell, D, Mich.) and companion bill S. 3 (Harry Reid, D, Nev.), which direct the secretary of HHS to negotiate Part D drug prices with drugmakers, including generic manufacturers.