A Message from Kathleen Jaeger: New Year, New Congress, New Hope for Generics

This year is going to be a busy one forthe generic pharmaceutical industry,with the new Congress making healthcare a top priority. As Congress grappleswith controlling escalating health carecosts and increasing access to qualitycare, issues impacting our industry willbe front and center in the debate.

Congress has a real opportunity toincrease patient access to safe, effective,and affordable generics during this session.Among the many issues on its plate,the new Congress must reauthorize thePrescription Drug User Fee Act (PDUFA),the Pediatric Research Equity Act (PREA),and the Trade Promotion Act (TPA).

Perhaps the liveliest debate will becentered on the need for the FDA to createa clear and effective abbreviatedpathway for the approval of generic biopharmaceuticals.Biopharmaceuticals areeveryday medicines used to treat conditionssuch as heart disease, rheumatoidarthritis, and cancer, yet their costs areincredibly high?sometimes as much as$200,000 per patient per year. Genericbiopharmaceuticals would bring competitioninto the health care system,reduce costs, and increase patientaccess. That is why groups like AARP, theConsumer Federation of America, andthe American Federation of Labor andCongress of Industrial Organizations areall supporting legislative efforts to bringmore affordable versions of these medicinesto patients.

PDUFA will also be a topic of muchdiscussion on Capitol Hill. As part ofPDUFA, the FDA has floated the idea ofrequiring that generic drug companiespay user fees to help fund the agency.The generic industry is open to talkingabout any options that would bring moreaffordable medicines to patients faster,but user fees cannot be discussed in avacuum. Paying user fees will not getdrugs to patients faster as long as barrierssuch as authorized generics and citizenpetitions exist.

That is why Congress needs to addressthe practice of authorized generics.When the Hatch-Waxman Act wascreated, Congress granted a 180-dayperiod of exclusivity to generic companiesto encourage competition andensure that checks and balances arebuilt into the approval system.Authorized generics have underminedcongressional intent, however, by devaluingthe 180-day exclusivity period,which is a critical incentive to bringgenerics to market in a timely manner.

Brand companies also use citizen petitionsto stall generic approvals. Accordingto a Merrill Lynch review of petitionsfiled between 2000 and 2005, 76%were dismissed by the FDA as having nomerit. These needless delays in approvalscost patients and the health caresystem millions of dollars. It is time forCongress to close these loopholes.

Another measure that must be renewedis the PREA. The generic industrystrongly supports the goal of the act?toprovide greater access to pediatric medicines?but we need to address the seriouslack of clinical information on thesafe and effective use of these medicinesin children. As it considers renewingthe act, Congress must determinewhether the American health care systemis receiving the best clinicalresearch and information in return for anadditional 6 months of exclusivity for theentire family line of the product studied.

Finally, Congress will be debating theTPA this year. Unfortunately, most freetrade agreements go beyond US law byproviding more intellectual propertyrights to the brand industry throughbrand patent extensions and marketexclusivity provisions. Even worse,these free trade agreements do notinclude one mandatory generic accessprovision. Quite simply, these agreementscan harm patients by delayingaccess to generics.

In reauthorizing the TPA, Congress canput patients back on the playing field. Itcan require that the Office of the USTrade Representative maintains a balancebetween pharmaceutical innovationand access to affordable medicinesfrom the start of their trade negotiations.Failure to balance the need for bothpharmaceutical innovation and accesswill hurt America's economy, the healthcare system, and the availability ofaffordable medicines worldwide.

The year 2007 can truly be a watershedyear for Congress?and patients?to reduce health care costs and increaseaccess to affordable generic medicines. Itwill be a busy session, but Congress hasa real opportunity to remove barriers toaccessing quality care and put controland choice in the hands of patients.

Kathleen Jaeger, GPhA president andchief executive officer