DeLauro to Introduce Legislation Enabling FDA Oversight Of Compounding Pharmacies

MeningitisOutbreak another Example of a Failed Regulatory Patchwork

NEWHAVEN, CT—Congresswoman Rosa DeLauro (CT-3) announced today she will beintroducing legislation to strengthen the Food and Drug Administration (FDA)'sauthority to ensure the safety of drugs from compounding pharmacies. Sucha facility is at the root of the current fungal meningitis outbreak that haskilled 11 people and sickened 119 in nine states. These pharmacies areintended to create customized versions of medicine for specific patients, notbulk production of medications, such as the estimated 17,000 steroid injectionstied to the outbreak. Currently the pharmacies are licensed and overseenby a patchwork of state agencies and the FDA's guidance to states on licensingsuch pharmacies was last updated in 2002. The pharmacy that produced thepotentially contaminated drug responsible for the current outbreak hassurrendered its license to the Massachusetts State Board of Pharmacy and allcompounds from the facility have been recalled.

DeLauroalso sent a letter to Health and Human Services Secretary Kathleen Sebeliusrequesting information about the gaps in our drug safety system posed bycompounded products and the need to better protect patients, including thoseenrolled in Medicare. "I believe this outbreak and corresponding recall makeclear that strong Federal authority is needed over these large scalecompounding pharmacies to ensure that patients receive safe and effectivedrugs, that we better monitor adverse events associated with these drugs, andthat there is a single entity responsible for verifying appropriate marketingand safe drug production," she wrote. "It is also critical that Federaland State partners responsible for this oversight have the resources andcapacity needed to complete this work."

DeLaurois a senior Democrat on the House of Representatives committee that funds theFDA and a longtime champion for strengthening oversight responsibilities andincreased funding for the agency. Details on the recall may be foundhereand information on the fungal meningitis outbreak may be found here.

Theletter is as follows:

October 9, 2012

TheHonorable Kathleen Sebelius

Secretary

Departmentof Health and Human Services

200Independence Avenue, S.W.

Washington,D.C. 20202

DearSecretary Sebelius:

I write todayout of grave concern regarding the ongoing outbreak of fungal meningitis thathas been linked to an epidural injection of a compounded drug. As oftoday, more than 100 cases of fungal meningitis, including 11 deaths, have beenlinked to a specific steroid injection drug produced by a single compoundingpharmacy center. This outbreak and the corresponding recall of productsfrom the New England Compounding Center expose dramatic gaps in our drug safetystandards that create an unnecessary risk to the public health.

I believe thisoutbreak and corresponding recall make clear that strong Federal authority isneeded over these large scale compounding pharmacies to ensure that patientsreceive safe and effective drugs, that we better monitor adverse eventsassociated with these drugs, and that there is a single entity responsible forverifying appropriate marketing and safe drug production. It is alsocritical that Federal and State partners responsible for this oversight havethe resources and capacity needed to complete this work.

As you know,drug compounding is traditionally viewed as the creation of a specific drug fora particular patient when there is not an alternative approved by the Food andDrug Administration (FDA). Compounded drugs may play a valuable role forsome patients and their health care providers based on the patients' specifichealth needs. A 2001 FDA survey, however, found that products fromcompounding pharmacies had a "higher than expected" failure rate, thus indicatingthat they may convey a different risk than other pharmaceutical products. Another FDA survey conducted in 2006 identified clear concerns about thesafety, potency, and uniformity of some compounded drugs.

Moreover, somecompounding pharmacies have evolved into large scale operations that producesizeable quantities of some drugs. For example, cases in the currentoutbreak are spread across nine states and more than 17,500 doses of thepotentially contaminated drug were shipped to twenty-three states. At thesame time, the FDA lacks clear authority for ensuring the safety of theseproducts and last updated its guidance for industry in 2002.

Because of thecurrent vague patchwork of Federal and State oversight and regulation of thesepharmacies, consumers are left at risk and often unaware of the differencesbetween these products and others. I believe that we must do more toensure the safety of these products for American consumers, to make certainthat consumers have the information they need to make an informed choice, andto verify that Medicare is accurately reimbursing for the use of these productssometimes used by our nation's seniors.

In light ofthese concerns and my intent to work to improve the safety of these products, Iwould appreciate your timely response to the following questions:

· How is your Department reaching out to healthcare providers and their patients to ensure that such a large possible patientpopulation is quickly and efficiently notified that their health may be at risk?

· How can your Department work with State partnersto ensure that compounding pharmacies and centers follow safe preparationtechniques to minimize the risk of contaminated products entering themarketplace?

· Which laboratory standards does the Departmentconsider to be the premier standard for these pharmacy facilities? Howcan the Department strengthen oversight of these centers and work to ensurethat the facilities comply with appropriate laboratory standards?

· Within your Department's existing authority, howcan HHS encourage reporting of adverse events with compounded drugs and monitorthose adverse events? Would additional authority, requiring the reportingof these adverse events, enable the agency to better protect the public healthand quickly communicate with patients and health care providers?

· What authorities does your Department believe itneeds to ensure that non-traditional compounding centers, such as the centerinvolved in this latest outbreak and recall, are appropriately regulated at theFederal level?

· How does your Department ensure the safety andefficacy of compounded drugs that are prescribed for patients enrolled inMedicare and reimbursed by the program?

· How does your Department conduct outreach toMedicare patient and health care providers to convey the risk of compoundeddrugs?

· How does your Department ensure that Medicarereimbursements do not inadvertently incentivize the use of compounded drugs?

Thank you foryour prompt attention to this critical public health issue. I lookforward to your response to these questions and to our continued work to ensurethe safety of the drugs used to treat American patients and to prevent futureoutbreaks like these.

Sincerely,

ROSA L. DeLAURO

Member ofCongress