Generic Industry Has the Wind at Its Back

When it comes to continued growth inthe generic pharmaceutical industry, "thewind is at our back," according to DougLong, vice president of industry relationsat IMS Health. Speaking at the GenericPharmaceutical Association's (GPhA's)Annual Policy Conference, Long notedthat the generic industry is growing atroughly 14%, a pace that is twice as fastas the world pharmaceutical market.

The reasons behind this substantialgrowth include the strong utilization ofgenerics through the Medicare prescriptiondrug benefit, an aging populationwith a growing reliance on medicines,and more than $50 billion inbrand products that will be coming offpatent during the next few years. Onlythe biotech sector is continuing togrow at a faster rate than generics, at17.9%. With the increased growth inthe biotech sector comes the hope ofmore cures, but also of increased costsfor patients. A biotech drug used totreat colon cancer, for example, costs$100,000 a year, with some biologicscosting many times more. With thosehigh biotech prices in mind, it was nosurprise that many conference speakersfocused on the need for Congressto approve legislation giving the FDAthe authority to approve generic versionsof biopharmaceuticals, or biogenerics.

"Now is the time to pass legislationenabling the FDA to create an abbreviatedregulatory pathway for safe, pure,and effective biogenerics," said ChristopherBegley, president and chiefexecutive officer of Hospira, Inc, whichis actively investing in the biogenericmarket. "When lifesaving drugs are notaffordable—regardless of their safetyand efficacy—they are irrelevant."

Congressman Frank Pallone (D,NJ),who chairs the House Energy and CommerceSubcommittee on Health,agreed on the need for Congress totake action on biogenerics. Althoughbiogenerics legislation was not includedas part of an FDA reform bill, Palloneasserted that the issue is still movingforward. Pallone pledged that theHouse of Representatives would continueto hold hearings on biogenericsand develop legislation in the comingmonths.

Biogenerics legislation is only one ofmany issues impacting the genericindustry. Conference speakers also discussedcitizen petitions and patentsystemreforms. Citizen petitions, whichcan deal with legal, regulatory, and scientificmatters, are often filed with theFDA on the eve of a generic application'sapproval. The vast majority aredismissed without merit. Unfortunately,as FDA Deputy CommissionerJanet Woodcock, MD, pointed out,regardless of their merit, citizen petitions"are very labor-intensive," andtheir review can delay generics fromcoming to market in a timely manner.The delay could be days or even years,giving the brand company a longermonopoly and costing patients millionsof dollars. Fortunately, legislation recentlyapproved by Congress wouldaddress citizen-petition abuse by requiringpetitions to be reviewed withina 6-month time period and would allowfor the simultaneous consideration ofthe generic application and the petition.

10th Annual IGPA Conference

For a look at the international genericpharmaceutical industry, join us forthe 10th Annual International GenericPharmaceutical Alliance (IGPA)Conference from November 28 toDecember 1, 2007, in Miami Beach,Fla. Details are available online atwww.gphaonline.org.

In addition, the House and Senateare considering patent-reform bills thatwould change the way generic companiesundertake patent challenges.Some lawmakers want to make changesto inequitable conduct, which enablesgeneric companies to challenge brandcompanies that use fraudulent statementsand misconduct to garnerpatents from the Patent and TrademarkOffice (PTO). Depending on how thechanges are made, it could result in thePTO mistakenly issuing patents or makeit more difficult for generic companiesto challenge questionable patents andbring an affordable medicine to market.The industry will be closely monitoringthe legislation.

Whether it is patent reform, biogenericslegislation, or other healthcare matters, decisions made by lawmakerson Capitol Hill will affect thestrength of the wind at the industry'sback in the future. The industry will beworking together to make sure that thewind is blowing in favor of increasingpatient access to safe, effective, andaffordable generics.