Reforming the Drug Compounding Regulatory Framework

No Comments Share:

Hearing Description:

The Health subcommittee recently met to continue their examination of drug compounders. During the hearing, the distinction between compounders and manufacturers was debated with no census being reached on a classification. In a partisan split, Republicans were hesitant to grant broader authority to the FDA to investigate reports of contamination They maintain the agency already has the authority to do so.

Hearing Date: July 16, 2013

Hearing Summary Prepared for AAPS by the Market Institute

The House Energy and Commerce Subcommittee on Health recently held a hearing examining the need for regulation in the drug compounding industry. Previously, hearings have been held discussing the issue, but the committee will continue to debate discussion draft legislation introduced by Rep. Morgan Griffith (R-VA). In his opening statement, Chairman Joe Pitts (R-PA) reminded everyone of the fungal meningitis outbreak last year that claimed the lives of 50 people due to a drug compounder distributing contaminated lots of drugs. The committee is looking forward to discussing the Griffith draft and hearing what witnesses have to say about it. The Griffith draft would ensure that drug compounding regulation remains at the state level, while it also clarifies the FDA’s authority more clearly over drug manufacturers.

Rep. Henry Waxman (D-CA) said in his opening statement that legislation needs to be tailored to the realities facing the FDA. The agency needs strong records checking authority. Also, non-traditional compounders should be required to register with the FDA.

Rep. Dr. Michael Burgess (R-TX) said in his opening statement he was willing to reaffirm the FDA’s authority to prevent future outbreaks, but was hesitant to grant the agency any new authority.

The first witness on the first panel, Janet Woodcock, Director at the Center for Drug Evaulation and Research (FDA) testified in her opening statement that the incident last year with the contaminated drugs originating from the New England Compounding Center (NECC) was not isolated. There have been multiple situations in which compounded products have caused deaths and injuries. The FDA is trying to investigate claims of contamination at pharmacies around the country, but in some cases, is being met with resistance. Administrative warrants were even necessary in two cases. It remains to be seen how effective the FDA’s regulatory action over drug compounders actually is. There is a clear need for legislation that not only clarifies the FDA’s authority, but empowers the agency to crack down on drug compounders and pharmacies that are considered bad actors.

In response to questioning, Janet Woodcock said:

  • The FDA needs more tools to prevent bad actors from circumventing drug review processes
  • There are problems actually finding outsources (non-traditional compounders) and thus enforcing regulations
  • The FDA has had difficulties coming up with a “coherent scheme” to judge compounders on volume of sales alone
  • There is very specific criteria for what drugs should not be compounded
  • The current system requires the FDA to go through the courts to investigate contaminated pharmacies; the process takes as long as two weeks
  • There are cases where state boards do not have the resources to partake in a joint investigation

The first witness on the second panel, B. Douglas Hoey, Chief Executive Officer at National Community Pharmacists Association testified in his opening statement that the NCPA supports the Griffith draft legislation as it is not a broad expansion of power for the FDA, but strikes a proper balance of protecting patients and preventing future tragedies. Community pharmacists play a vital role in the care of patients and any legislation that would affect their ability to do so would be a detriment. The state board of pharmacy should remain the principal regulator of compounders and pharmacies. However, strengthening the communication between the FDA and state boards is critical in preventing future incidents.

The second witness on the second panel, Kasey Thompson, Vice President at American Society of Health-System Pharmacists testified in his opening statement there is concern state board of pharmacies do not have sufficient resources to oversee large-scale drug compounders. The FDA needs to the ability to inspect potential bad actors without having to first go through state boards. The current regulatory framework does not allow for the FDA to investigate claims of contamination without receiving a request from the state board of pharmacy. Removing this roadblock would also create accountability for the agency.

The third witness on the second panel, Jeffrey Francer, Assistant General Counsel at Pharmaceutical Research and Manufacturers of America testified in his opening statement that patients would be better served by Congress passing legislation clarifying the FDA’s authority over non-traditional compounders. The agency should be able to take the same risk-based approach towards compounders that they do with manufacturers. However, PhRMA does not believe that at new classification of compounder is not necessary. Creating a “compounding manufacturer” distinction would only add to the confusion at the federal and state level of regulation.

The fourth witness on the second panel, David Gaugh, Senior Vice President for Sciences and Regulatory Affairs at Generic Pharmaceutical Association testified in his opening statement that GPhA support the goal of clarifying the FDA’s authority over compounders, but also stresses the importance of the services that traditional compounders provide to patients. The bulk products used in compounding should be held to high standards. The FDA should receive notices from large-scale compounders prior to the marketing of the compound. In addition, the FDA should be able to inspect compounds prior to their release into the marketplace.

The fifth witness on the second panel, Allan Coukell, Senior Director – Drug and Medical Devices at The Pew Charitable Trusts testified in his opening statement that standards set forth for compounds should fall under oversight of the FDA and not state boards. A challenging aspect of this regulatory framework is deciding what facilities should fall under FDA oversight. There is no simple solution, rather these factors should be taken into account: volume of production, nature of the products, percentage of sales, expiry dates, and interstate sales. All of those factors play a role into whether the compounder is large enough to warrant FDA oversight. The FDA should also be able to enforce a “do not compound” list and retain the ability to inspect compounders at their discretion.

The sixth witness on the second panel, David G. Miller, Executive Vice President and CEO at International Academy of Compounding Pharmacists testified in his opening statement that there are concerns over provisions in the Senate legislation that would severely prohibit pharmacists from meeting demand and physicians from keeping office-use compounds on hand. Another significant flaw in the bill is a lack of a reporting system to hold the FDA accountable. The Griffith proposal in the House is more in line with that thinking. There is more room for accountability, while largely keeping the regulation over compounders in the states’ hands.

The final witness on the second panel, Carmen Catizone, Executive Director at National Association of Boards of Pharmacy testified the NABP supports the Senate provision in that traditional compounders should remain under the purview of the states and manufacturers should remain under the purview of the FDA. Additionally, they support the creation of a new category, compounding manufacturers, that would also be regulated by the FDA. The creation of the third category seems to address the needs of the majority of patients.

In response to questioning, Jeffrey Francer said:

  • The FDA is currently fit to regulate pharmaceutical manufacturers and does not need an expansion of authority

In response to questioning, David Miller said:

  • The act of going across a state line should not be a trigger for FDA authority; American healthcare system is too complex for that to apply
  • There is no easy way to determine where the line distinguishes pharmacies and manufacturers, but multiple qualifiers (volume, % of sales, etc) would aid in that distinction

Hearing Website:
http://energycommerce.house.gov/hearing/reforming-drug-compounding-regulatory-framework

Testimony:

Janet Woodcock, M.D.
Director
Center for Drug Evaluation and Research
Food and Drug Administration (FDA)

Jeffrey Francer
Assistant General Counsel
Pharmaceutical Research and Manufacturers of America

David Gaugh
Senior Vice President for Sciences and Regulatory Affairs
Generic Pharmaceutical Association

B. Douglas Hoey
Chief Executive Officer
National Community Pharmacists Association

David G. Miller
Executive Vice President and CEO
International Academy of Compounding Pharmacists

Carmen Catizone
Executive Director
National Association of Boards of Pharmacy

Kasey Thompson
Vice President
American Society of Health-System Pharmacists

Allan Coukell
Senior Director, Drug and Medical Devices
The Pew Charitable Trusts

Related Articles

Scroll Up