Government Should Focus on Patient Needs

Author: Kathleen Jaeger, GPhA president and CEO

Kathleen Jaeger, GPhA president and chief executive officer

Later this year, Americans will be heading to the polls to vote for candidates they believe will make the best decisions to help them lead safer, healthier, more productive lives.

In fact, Americans are telling their elected officials that one of their highest priorities is access to quality, affordable health care. With health care costs continuing to escalate, it is an issue that candidates and state and federal government officials cannot afford to ignore.

Increasingly, families are recognizing that one key way to achieve better health at lower costs is to switch to safe, effective, and affordable generic medicines. Today, 63% of Americans are choosing generic medicines to fill their prescriptions. It is not hard to understand why: generics provide the same medicine and the same results as their brand counterparts, but at a significantly lower cost.

In 2008, the generic industry will continue to take steps to ensure that those affordable medicines reach patients in a timely manner. We are working hard to let lawmakers know how important generics are to patients and the health care system.

We are focused on approving legislation to create an FDA approval pathway for biogenerics, or generic versions of biopharmaceutical products. Legislation would provide patients with access to safe, effective, and affordable life-saving medicines, which are used to treat conditions such as diabetes and cancer. More than 70 organizations and governors have joined GPhA's efforts in support of legislation.

This year, we will face a mounting push for extending market exclusivity for brand biopharmaceuticals. GPhA believes strongly that extending market exclusivity puts brand profits ahead of patient needs by delaying timely access to affordable biogenerics. If Congress is serious about getting safe biogenerics into the hands of patients, it must ensure that it does not tie the generic industry's hands by granting the brand companies excessive market exclusivity— which translates into longer brand product monopolies, to the detriment of patients.

We also are monitoring patent reform, which is currently under debate in Congress. Although it is important to enhance the integrity of the patent process, the industry is concerned that some of the provisions under consideration would undermine the objective to achieve real reform. Specifically, the industry opposes efforts to change inequitable conduct, which ensures that dubious patents are not preserved, and best mode, which is critical to promoting efficient use of scientific resources. Both measures are vital to bringing affordable generics to market.

Other issues that will be at stake include counterfeiting and pedigree measures, authorized generics, and free trade agreements. We have joined with a coalition, Rx Safe- Track, on possible anti-counterfeiting and pedigree measures to ensure that medicines can be traced throughout the supply chain. On authorized generics, we are working to close a loophole used by brand companies to discourage generic companies from challenging questionable brand patents. And on free trade agreements, our goal is to achieve what we did this past fall in the United States?Peru Free Trade Agreement— Congressional passage of an agreement that maintains a balance between encouraging innovation and allowing access to generic medicines.

There is no doubt that 2008 will be an exciting year in the political and legislative arenas, and GPhA will be working hard to ensure that the right choices are made to improve Americans' health for less.