Committee to Hold Hearing on Drug Compounding Challenges Related to Fungal Meningitis Outbreak
the Drug Compounding Regulatory Framework,” on Tuesday, July 16, 2013. The hearing webcast will be available at http://energycommerce.house.gov/.
Those scheduled to provide testimony at the hearing include:
- Janet Woodcock, MD, director of the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA)
- Jeffrey Francer, assistant general counsel for Pharmaceutical Research and Manufacturers of America
- David Gaugh, senior vice president of sciences and regulatory affairs for Generic Pharmaceutical Association
- B. Douglas Hoey, CEO of the National Community Pharmacists Association
- David G. Miller, executive Vvice president and CEO of the International Academy of Compounding Pharmacists
- Carmen Catizone, executive director of the National Association of Boards of Pharmacy
- Kasey Thompson, vice president of the American Society of Health-System Pharmacists
- Allan Coukell, senior director of drug andmedical devices for The Pew Charitable Trusts
Traditional drug compounding provides a valuable medical service to patients across the country. According to FDA, it “regards traditional pharmacy compounding as the combining or altering of ingredients by a licensed pharmacist, in response to a licensed practitioner’s prescription for an individual patient, which produces a medication tailored to that patient’s special medical needs.”
In the summer and fall of 2012, a Massachusetts company, the New England Compounding Center (NECC), shipped over 17,000 vials of an injectable steroid solution from three contaminated lots to healthcare facilities across the country. After receiving injections of NECC’s contaminated steroid, over 50 people died from complications associated with fungal meningitis. Further, almost 700 others were stricken with meningitis or other persistentfungal infections . The outbreak ranks as one of the worst public health crises associated with contaminated drugs in the history of the United States.
The Oversight and Investigations Subcommittee (O&I Subcommittee) held its first hearing on the outbreak on Nov. 14, 2012, “The Fungal Meningitis Outbreak: Could It Have Been Prevented?” After FDA finally complied with the Committee’s document request, the O&I Subcommittee held a second hearing on the outbreak on April 16, 2013, “A Continuing Investigation into the Fungal Meningitis Outbreak and Whether It Could Have Been Prevented.” In conjunction with the second hearing, the O&I Subcommittee produced areport on its investigation outlining the issues caused by NECC.
On May 23, 2013, the Health Subcommittee held a hearing, “Examining Drug Compounding.” The hearing provided the Subcommittee with a better understanding of the role of compounding in the U.S. health system and the challenges of regulating the compounding industry.
During Tuesday's hearing, the Health Subcommittee will hear from FDA and healthcare experts regarding the legislative proposals released since the outbreak, including:
- “The Compounding Clarity Act” authored by Rep. Morgan Griffith
- H.R. 2186 “Verifying Authority and Legality in Drug Compounding Act of 2013” sponsored by Rep. Ed Markey
- S. 959 “Pharmaceutical Compounding Quality and Accountability Act” sponsored by Sen. Tom Harkin
In advance of Tuesday's hearing, “Reforming the Drug Compounding Regulatory Framework," the Premier healthcare alliance provided the following statement for the record:
"Not-for-profit hospitals created Premier as a way to better serve their patients by overcoming the challenges posed by our fragmented healthcare system. A key component of our alliance is that clinical sourcing decisions are made by approximately 370 individuals, representing 180 hospitals that sit on 23 strategic and sourcing committees and these individuals use their professional, objective knowledge and judgment to select products on behalf of the alliance. Several of these sourcing committees are responsible for the evaluation and selection of safe, effectivepharmaceutical products for the Premier Pharmacy Program. Premier’s pharmacy department contracts include more than 150 suppliers and more than 13,000 different products making it one of the largest of the group purchasing organizations (GPOs).
"Last year’s deadly meningitis outbreak, which the Centers for Disease Control and Prevention linked to tainted products compounded by the New England Compounding Center (NECC) pharmacy, has caused alarm among patients and providers across the nation. The Premier healthcare alliance commends the Committee for holding this hearing to address the concerns of patients and healthcare providers about needed oversight to ensure that drugs being administered to patients by hospitals, physicians and other providers are safe and effective.
"In a recent Premier survey of health system pharmacists, nearly 90 percent of the respondents believethat greater legislation and/or regulatory oversight is needed to improve drug safety. As thecompounding industry grows, clarification is needed to clear up regulatory confusion and ensure gapsare closed in oversight of “compounding manufacturers.” Premier strongly supports a policy approachthat clearly defines the two types of drug compounders—traditional compounders and compounding
manufacturers—and the development of separate but related regulatory oversight and enforcementmechanisms. State licensed pharmacies and hospital pharmacies are rightfully the subject of statepharmacy law and state pharmacy board regulation and oversight, as has traditionally been the case.
"By contrast, compounding manufacturers prepare their compounded sterile products for sale without a prescription and for no specific patient prescription; they are clearly engaging in regular interstate commerce and should be subject to oversight and regulation at the federal level by the Food and Drug Administration (FDA). The compounding is done on a larger scale than in traditional pharmacies, often for sale anywhere in the United States, and therefore more closely resembles manufacturing.
"The Premier healthcare alliance does not and has never entered into a group purchasing agreement for high-risk sterile compounding pharmacies, which, as defined by the United States Pharmacopeial Convention (USP) chapter <797> guidelines, typically mix compounded sterile preparations with nonsterile ingredients as the initial component. However, the Premier survey revealed the need for hospitals and health systems to have access to safe pharmaceuticals from compounding manufacturers in situations such as:
• When the product is not commercially available from traditional manufacturers (it is unlawful to compound drugs that are commercially available) or there is a drug shortage of a particular product
• When products with a longer shelf life are needed than what can be compounded by hospital/health system pharmacists
• When hospital and health system pharmacists lack the staff resources to produce compounded sterile preparations.
"Hospital and health systems are currently subject to a number of regulatory requirements from both federal and state agencies to ensure safe patient care and health delivery processes. For example, the Centers for Medicare & Medicaid Services imposes strict conditions of participation on hospitals and health systems. Hospitals and health systems must also adhere to United States Pharmacopeial Convention guidelines and hospital accreditation standards (e.g., The Joint Commission) governing pharmaceutical compounding in anticipation of own use. Hospital and health system pharmacies are also subject to state pharmacy board regulations and oversight. Hospital and health system pharmacies compound drugs to address the needs of identifiable patients pursuant to a prescription order, which is the fundamental distinction between traditional compounders and compounding manufacturers. Hospital and health system pharmacies do not compound drugs for resale outside their systems; the practice has been, and will continue to be, the transfer of compounded drugs within the hospital or health system for use in the treatment of specific, identifiable patients. The hospital and health system take the responsibility not only for the preparation of the compounded drug but also its administration to the patient and associated monitoring and care.
"Premier greatly appreciates the Committee’s review of compounded drugs provided to patients and we stand ready to help Congress find achievable ways to ensure their effectiveness and safety."
source found here
Those scheduled to provide testimony at the hearing include:
- Janet Woodcock, MD, director of the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA)
- Jeffrey Francer, assistant general counsel for Pharmaceutical Research and Manufacturers of America
- David Gaugh, senior vice president of sciences and regulatory affairs for Generic Pharmaceutical Association
- B. Douglas Hoey, CEO of the National Community Pharmacists Association
- David G. Miller, executive Vvice president and CEO of the International Academy of Compounding Pharmacists
- Carmen Catizone, executive director of the National Association of Boards of Pharmacy
- Kasey Thompson, vice president of the American Society of Health-System Pharmacists
- Allan Coukell, senior director of drug and
Traditional drug compounding provides a valuable medical service to patients across the country. According to FDA, it “regards traditional pharmacy compounding as the combining or altering of ingredients by a licensed pharmacist, in response to a licensed practitioner’s prescription for an individual patient, which produces a medication tailored to that patient’s special medical needs.”
In the summer and fall of 2012, a Massachusetts company, the New England Compounding Center (NECC), shipped over 17,000 vials of an injectable steroid solution from three contaminated lots to healthcare facilities across the country. After receiving injections of NECC’s contaminated steroid, over 50 people died from complications associated with fungal meningitis. Further, almost 700 others were stricken with meningitis or other persistent
The Oversight and Investigations Subcommittee (O&I Subcommittee) held its first hearing on the outbreak on Nov. 14, 2012, “The Fungal Meningitis Outbreak: Could It Have Been Prevented?” After FDA finally complied with the Committee’s document request, the O&I Subcommittee held a second hearing on the outbreak on April 16, 2013, “A Continuing Investigation into the Fungal Meningitis Outbreak and Whether It Could Have Been Prevented.” In conjunction with the second hearing, the O&I Subcommittee produced areport on its investigation outlining the issues caused by NECC.
On May 23, 2013, the Health Subcommittee held a hearing, “Examining Drug Compounding.” The hearing provided the Subcommittee with a better understanding of the role of compounding in the U.S. health system and the challenges of regulating the compounding industry.
During Tuesday's hearing, the Health Subcommittee will hear from FDA and healthcare experts regarding the legislative proposals released since the outbreak, including:
- “The Compounding Clarity Act” authored by Rep. Morgan Griffith
- H.R. 2186 “Verifying Authority and Legality in Drug Compounding Act of 2013” sponsored by Rep. Ed Markey
- S. 959 “Pharmaceutical Compounding Quality and Accountability Act” sponsored by Sen. Tom Harkin
In advance of Tuesday's hearing, “Reforming the Drug Compounding Regulatory Framework," the Premier healthcare alliance provided the following statement for the record:
"Not-for-profit hospitals created Premier as a way to better serve their patients by overcoming the challenges posed by our fragmented healthcare system. A key component of our alliance is that clinical sourcing decisions are made by approximately 370 individuals, representing 180 hospitals that sit on 23 strategic and sourcing committees and these individuals use their professional, objective knowledge and judgment to select products on behalf of the alliance. Several of these sourcing committees are responsible for the evaluation and selection of safe, effective
"Last year’s deadly meningitis outbreak, which the Centers for Disease Control and Prevention linked to tainted products compounded by the New England Compounding Center (NECC) pharmacy, has caused alarm among patients and providers across the nation. The Premier healthcare alliance commends the Committee for holding this hearing to address the concerns of patients and healthcare providers about needed oversight to ensure that drugs being administered to patients by hospitals, physicians and other providers are safe and effective.
"In a recent Premier survey of health system pharmacists, nearly 90 percent of the respondents believethat greater legislation and/or regulatory oversight is needed to improve drug safety. As thecompounding industry grows, clarification is needed to clear up regulatory confusion and ensure gapsare closed in oversight of “compounding manufacturers.” Premier strongly supports a policy approachthat clearly defines the two types of drug compounders—traditional compounders and compounding
manufacturers—and the development of separate but related regulatory oversight and enforcementmechanisms. State licensed pharmacies and hospital pharmacies are rightfully the subject of statepharmacy law and state pharmacy board regulation and oversight, as has traditionally been the case.
"By contrast, compounding manufacturers prepare their compounded sterile products for sale without a prescription and for no specific patient prescription; they are clearly engaging in regular interstate commerce and should be subject to oversight and regulation at the federal level by the Food and Drug Administration (FDA). The compounding is done on a larger scale than in traditional pharmacies, often for sale anywhere in the United States, and therefore more closely resembles manufacturing.
"The Premier healthcare alliance does not and has never entered into a group purchasing agreement for high-risk sterile compounding pharmacies, which, as defined by the United States Pharmacopeial Convention (USP) chapter <797> guidelines, typically mix compounded sterile preparations with nonsterile ingredients as the initial component. However, the Premier survey revealed the need for hospitals and health systems to have access to safe pharmaceuticals from compounding manufacturers in situations such as:
• When the product is not commercially available from traditional manufacturers (it is unlawful to compound drugs that are commercially available) or there is a drug shortage of a particular product
• When products with a longer shelf life are needed than what can be compounded by hospital/health system pharmacists
• When hospital and health system pharmacists lack the staff resources to produce compounded sterile preparations.
"Hospital and health systems are currently subject to a number of regulatory requirements from both federal and state agencies to ensure safe patient care and health delivery processes. For example, the Centers for Medicare & Medicaid Services imposes strict conditions of participation on hospitals and health systems. Hospitals and health systems must also adhere to United States Pharmacopeial Convention guidelines and hospital accreditation standards (e.g., The Joint Commission) governing pharmaceutical compounding in anticipation of own use. Hospital and health system pharmacies are also subject to state pharmacy board regulations and oversight. Hospital and health system pharmacies compound drugs to address the needs of identifiable patients pursuant to a prescription order, which is the fundamental distinction between traditional compounders and compounding manufacturers. Hospital and health system pharmacies do not compound drugs for resale outside their systems; the practice has been, and will continue to be, the transfer of compounded drugs within the hospital or health system for use in the treatment of specific, identifiable patients. The hospital and health system take the responsibility not only for the preparation of the compounded drug but also its administration to the patient and associated monitoring and care.
"Premier greatly appreciates the Committee’s review of compounded drugs provided to patients and we stand ready to help Congress find achievable ways to ensure their effectiveness and safety."
source found here