A Message from Kathleen Jaeger: Congress Needs to Act Now to Approve Biogenerics

Congress is currently consideringimportant legislation that could helpcountless Americans gain access to themedicines they need, while savingpatients and the health care system billionsof dollars annually. This legislation,the Access to Life-Saving Medicine Act,would give the FDA the legal authority tocreate a clear, efficient abbreviatedapproval pathway for safe and effectivebiogenerics. The act also would providethe FDA with the flexibility to let soundscience drive the approval process toensure safety and efficacy.

It is critical to bring biogenerics to themarket because biopharmaceutical medicines,which are used to treat conditionssuch as multiple sclerosis, diabetes, andcancer, are extremely expensive. Withsome prices exceeding $200,000 perpatient per year, biopharmaceuticals areinaccessible for many Americans. Healthcare providers, such as the CaliforniaPublic Employees Retirement System(CalPERS), are concerned about the highcosts. In fact, CalPERS found that, onaverage, its spending for biotech productswas at least $55 per day—comparedwith traditional drugs at only $2per day. Given those costs, biogenericscould offer patients access to lifesavingtreatments at an affordable price. Even amodest reduction of 10% to 25% in costswould amount to billions of dollars insavings to patients and the health caresystem. According to a study released bythe Pharmaceutical Care Management Association,biogenerics would save theMedicare Part B program alone $14 billionover 10 years.

The Access to Life-Saving Medicine Actwould bring affordable biogenerics tomarket, but, most important, it wouldbring safe and effective biogenerics topatients—biogenerics approved usingadvanced scientific analytical tools.Specifically, the act would ensure thesafety of biogenerics by giving the FDAsole authority to determine what dataand tests it needs, on a product-by-productbasis, prior to approval. With morethan 20 years of experience in reviewingbiopharmaceutical products and thebenefit of significant scientific and technologicaladvances, the FDA clearly hasthe tools and know-how to approve biogenerics.In fact, the FDA has said thattoday's science supports the review andapproval of biogenerics with low-tomodestcomplexity.

Scientists with expertise in biopharmaceuticalsagree. Theresa Gerrard, PhD, aformer FDA official and former director ofdevelopment for a brand biotech company,has noted that the FDA currentlyreviews the data from sophisticated andadvanced scientific analytical tools toassess the impact of changes made bythe brand companies to their biopharmaceuticalproducts. "These analytical testshave been deemed to be the most sensitivetechnologies to ensure safety andefficacy of products that are changed bythe brands,"Dr. Gerrard said in congressionaltestimony.

She added, "Using the same scientificprinciples that were the basis for thiscurrent effective process for testingcomparability, it is scientifically soundand practical to approve biogenericsbased on a clear and efficient abbreviatedapproval pathway that will ensuresafety and efficacy."

Similarly, Bill Schwieterman, MD, a formerFDA official and consultant on biopharmaceuticalproducts for brand companies,said, "Despite what others in thisdebate may have implied, biogenericscan and will be safe for patient use andmay be therapeutically interchangeable. Isay this because the opposition completelyignores the FDA's scientific andmedical prowess in this debate. It is clearto me there is just one agency safetystandard. And that standard has been,and will continue to be, applied in the reviewand approval of each and every biologic—whether it is a brand or generic."

Given today's scientific advances andthe potential for significant savings, morethan 50 diverse organizations representingtens of millions of Americans are supportingthe legislation and calling onCongress to take action. These groupsinclude AARP, the AFL-CIO, and a coalitionof large national employers, healthplans, pharmacy benefit managers, chainpharmacies, and generic drug manufacturers,all of which are working to promoteaccess to safe and affordable qualityhealth care.

The time is now for Congress to passthe Access to Life-Saving Medicine Act,and lawmakers need to know howimportant this issue is to patients and thehealth care system. Please visit www.gphaonline.org and click on the "ContactCongress"tab to urge Congress to passthis important legislation without furtherdelay.

Kathleen Jaeger, GPhA president andchief executive officer