Government Should Focus on Patient Needs

Kathleen Jaeger, GPhA president and chief executive officer

Later this year, Americanswill be heading to the pollsto vote for candidates theybelieve will make the bestdecisions to help them lead safer,healthier, more productive lives.

In fact, Americans are telling theirelected officials that one of theirhighest priorities is access to quality,affordable health care. With healthcare costs continuing to escalate, it isan issue that candidates and stateand federal government officials cannotafford to ignore.

Increasingly, families are recognizingthat one key way to achieve betterhealth at lower costs is to switch tosafe, effective, and affordable genericmedicines. Today, 63% of Americansare choosing generic medicines to filltheir prescriptions. It is not hard tounderstand why: generics provide thesame medicine and the same results astheir brand counterparts, but at a significantlylower cost.

In 2008, the generic industry willcontinue to take steps to ensure thatthose affordable medicines reachpatients in a timely manner. We areworking hard to let lawmakers knowhow important generics are topatients and the health care system.

We are focused on approving legislationto create an FDA approvalpathway for biogenerics, or genericversions of biopharmaceutical products.Legislation would providepatients with access to safe, effective,and affordable life-saving medicines,which are used to treat conditionssuch as diabetes and cancer. Morethan 70 organizations and governorshave joined GPhA's efforts in supportof legislation.

This year, we will face a mountingpush for extending market exclusivityfor brand biopharmaceuticals.GPhA believes strongly that extendingmarket exclusivity puts brandprofits ahead of patient needs bydelaying timely access to affordablebiogenerics. If Congress is seriousabout getting safe biogenerics intothe hands of patients, it must ensurethat it does not tie the generic industry'shands by granting the brandcompanies excessive market exclusivity—which translates into longerbrand product monopolies, to thedetriment of patients.

We also are monitoring patentreform, which is currently underdebate in Congress. Although it isimportant to enhance the integrity ofthe patent process, the industry isconcerned that some of the provisionsunder consideration wouldundermine the objective to achievereal reform. Specifically, the industryopposes efforts to change inequitableconduct, which ensures that dubiouspatents are not preserved, and bestmode, which is critical to promotingefficient use of scientific resources.Both measures are vital to bringingaffordable generics to market.

Other issues that will be at stakeinclude counterfeiting and pedigreemeasures, authorized generics, andfree trade agreements. We havejoined with a coalition, Rx Safe-Track, on possible anti-counterfeitingand pedigree measures to ensure thatmedicines can be traced throughoutthe supply chain. On authorizedgenerics, we are working to close aloophole used by brand companies todiscourage generic companies fromchallenging questionable brandpatents. And on free trade agreements,our goal is to achieve what wedid this past fall in the UnitedStates?Peru Free Trade Agreement—Congressional passage of an agreementthat maintains a balancebetween encouraging innovation andallowing access to generic medicines.

There is no doubt that 2008 will bean exciting year in the political andlegislative arenas, and GPhA will beworking hard to ensure that the rightchoices are made to improveAmericans' health for less.