Showing posts with label GOA. Show all posts
Showing posts with label GOA. Show all posts

Wednesday, July 31, 2013

DRUG COMPOUNDING: Clear Authority and More Reliable Data Needed to Strengthen FDA Oversight GAO-13-702, Jul 31, 2013

50 page report is available http://www.gao.gov/products/GAO-13-702?source=rahere

What GAO Found

The authority of the Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), to oversee drug compounding is unclear. Two federal circuit court decisions have resulted in differing FDA authority in different parts of the country. According to FDA officials, these inconsistent decisions and the agency's limited inspection authority over pharmacies have created challenges in FDA's ability to inspect and take enforcement action against entities engaging in drug compounding. For example, from 2002 through 2012, in order to inspect some facilities engaged in drug compounding, FDA officials said they had to obtain 11 warrants to gain access to drug compounders' facilities that had challenged FDA's inspection authority. GAO also found that while FDA and national pharmacy organization officials generally agreed that states regulate the practice of pharmacy and FDA regulates drug manufacturing, there was no consensus on whether compounding drugs in large quantities--in anticipation of individual prescriptions or without prescriptions--and selling those drugs across state lines falls within the practice of pharmacy or is a type of drug manufacturing that should be overseen by FDA. This lack of consensus and differing FDA authority to oversee compounded drugs across the country has resulted in gaps in oversight of drug compounding.
FDA lacks timely and reliable information to oversee the entities that compound drugs, but has found problems through its limited oversight. Specifically, FDA's inspection database cannot identify all of the agency's inspections of compounding pharmacies, or the final classification of inspection results, for all of the inspections. Until 2013, FDA limited its inspections of compounding pharmacies to those conducted in response to complaints or adverse events. However, the agency recently inspected compounding pharmacies that it identified as posing a significant threat to public health from poor sterile drug production practices in the past and found problems, such as concerns about a lack of sterility, which resulted in recalls of compounded drugs. In addition, drug manufacturers are required to register with FDA and are subject to FDA's inspection and drug approval processes; pharmacies meeting certain requirements are generally exempt from registration. However, some compounding pharmacies may have registered with FDA to market themselves as "FDA-registered" which may lead some purchasers to assume that FDA has inspected or approved their compounded drugs; whereas, according to FDA officials, this is generally not the case.
The states GAO reviewed--California, Connecticut, Florida, and Iowa--have each taken actions to enhance their oversight of drug compounding. For example, Florida required all pharmacies--both those located in the state and out-of-state that sell drugs in Florida--to notify the board of their compounding activities. In addition, national pharmacy organizations have undertaken efforts to help states oversee drug compounding. For example, a national pharmacy organization is working with Iowa to inspect out-of-state pharmacies that ship drugs into the state. However, according to national pharmacy organizations and officials from state boards of pharmacy, some states do not have the resources to inspect pharmacies on a regular basis. Instead, these states inspect pharmacies only in response to a complaint or a reported adverse drug event.

Why GAO Did This Study

Drug compounding is the process by which a pharmacist combines, mixes, or alters ingredients to create a drug tailored to the medical needs of an individual. An outbreak of fungal meningitis in 2012 linked to contaminated compounded drugs has raised concerns about state and federal oversight of drug compounding. GAO was asked to update its 2003 testimony on drug compounding. Specifically, this report addresses (1) the status of FDA's authority to oversee drug compounding, and the gaps, if any, between state and federal authority; (2) how FDA has used its data and authority to oversee drug compounding; and (3) the actions taken or planned by states or national pharmacy organizations to improve oversight of drug compounding. GAO reviewed relevant statutes and guidance; reviewed FDA data; and interviewed officials from FDA, national pharmacy organizations, and four states with varied geography, population, and pharmacy regulations.

What GAO Recommends

To help ensure that the entities that compound drugs have appropriate oversight, Congress should consider clarifying FDA’s authority to oversee drug compounding. In addition, FDA should ensure its databases collect reliable and timely data on inspections associated with compounded drugs, and differentiate drug compounders from manufacturers. HHS's comments support the need to clarify FDA's authority, and stated that the information in its inspection database could be improved and that it would consider whether it can differentiate compounding pharmacies from manufacturers.

Monday, November 19, 2012

2003 United States General Accounting Office(GOA) Study: What Will the Next GOA Look Like?

Below is a portion of the statement of Janet Heinrich: Director, Health Care--Public Health Issues, about the GAO study conduct in 2003 regarding compounding pharmacies:

My testimony today is based in part on discussions with the National Association of Boards of Pharmacy (NABP), as well as a review we conducted of four states: Missouri, North Carolina, Vermont, and Wyoming. We selected these states based on their geographic location and variation in compounding regulations. Two of the states came to our attention as having taken unique steps with regard to oversight of compounded drugs, and the other two had each adopted new regulations on drug compounding. For each of the four states, we reviewed state statutes and regulations, interviewed officials from the state board of pharmacy, and reviewed relevant documents such as pharmacy inspection forms. In addition to examining state-level actions, we examined national industry efforts by interviewing officials from the American Pharmacists Association, the International Academy of Compounding Pharmacists, the American Society of Health-System Pharmacists, the National Association of Chain Drug Stores, and Professional Compounding Centers of America, which provides training to pharmacists and also sells bulk ingredients for drug compounding. We also contacted and obtained information from the United States Pharmacopeia (USP), which is a nonprofit agency that develops standards for pharmaceuticals. Finally, to examine federal authority and enforcement power, we reviewed federal statutes, FDA compliance policy guides, court decisions, and other relevant documents, and interviewed FDA officials and industry experts. We conducted our work from August 2003 to October 2003 in accordance with generally accepted government auditing standards. In summary, efforts at the state level and among pharmacy organizations at the national level have been taken or are under way to potentially strengthen state oversight of drug compounding. Actions among the four states we reviewed included adopting new statutes and regulations about compounding, such as requirements for facilities and equipment, and conducting more extensive testing of compounded drugs. For example, the pharmacy board in Missouri is starting a program of random testing of compounded drugs for safety, quality, and potency. At the national level, industry organizations are working on standards for compounded drugs that could be adopted by the states in their laws and regulations, thereby helping to ensure that pharmacies consistently produce safe, high-quality compounded drugs. While these actions may help improve oversight, the ability of states to oversee and ensure the quality and safety of compounded drugs may be affected by state- specific factors such as the resources available for inspections and enforcement. For example, in three of the four states we reviewed, pharmacy board officials indicated that resource limitations affected their ability to conduct routine inspections.

It will be interesting to see how the study recently ordered by Congress compares to this 2003 study.  To view the entire statement of  Heinrich click here.  To view the 2003 GOA study click here