When it comes to pharmaceutical compounding, the US Food and Drug Administration (FDA) knows it has a significant problem on its hands. But as Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), explained to a Senate committee on 9 May 2013, the biggest problem of all may be that FDA has no idea as to the extent of the problem it faces because companies aren't required to report safety problems to it.
The 9 May hearing was being held by the Senate's Health, Education, Labor and Pensions Committee, the body with oversight authority over FDA and much of the US healthcare system, to discuss a recently released legislative draft meant to improve the way the US regulates the practice of pharmaceutical compounding.
The issue has vaulted to the forefront of legislators' minds in recent months after a massive outbreak of fungal meningitis caused by a compounded product killed more than 50 people. A steady drumbeat of recalls and deficient inspection findings by FDA investigators have further accentuated the size and scope of the problems facing the industry, which include a lack of manufacturing standards, common deficiencies, rampant sterility violations, and a lack of inspectional authority for FDA.
Editor's Note: For more, please read our extensive coverage of pharmaceutical compounding issues here.
For legislators, these issues raise an obvious question: How do you fix these problems so that they don't happen again?
The answer, at least for the HELP Committee, can be found in their discussion draft, released on 25 April 2013. That draft calls for many changes petitioned for by FDA: Inspectional authority over compounders, user fees, a ban on difficult-to-manufacture sterile drugs and products approved by FDA and new categories for compounders.
And while the draft hasn't been without its detractors, it got some much-needed support during the 9 May 2013 hearing from Woodcock, who provided lengthy testimony regarding the problems FDA faces on a continual basis.
"As we have noted in the past, our ability to take action against inappropriate compounding practices has been hampered by ambiguities regarding FDA's enforcement authority, legal challenges, and adverse court decisions, and we have learned that the law is not well-suited to effectively regulate this evolving industry," Woodcock said. In some cases, companies are still requiring FDA and state inspectors to obtain administrative warrants before being allowed to access manufacturing records, significantly delaying their efforts to determine whether a facility is compliant with state and federal regulations.
Woodcock continued that the biggest problem facing regulators is simply that they don't know how many patients have been harmed by pharmaceutical compounding problems. With the exception of the New England Compounding Center, the company at the center of a massive, multi-state outbreak of fungal meningitis, it can be difficult to determine when a facility is connected with a disease outbreak.
'Not an Isolated Incident'
"Sadly, NECC was not an isolated incident," Woodcock noted. FDA is aware of at least eight other major incidents involving compounded drugs. But, as she admitted in an exchange with Massachusetts Sen. Elizabeth Warren, that number could well be much higher. "I think the real problem is that we don't know," she responded when prompted by Warren to explain how many patients have been harmed over the last two decades by compounded drugs. "There's no requirement right now for registration and listing, which would be telling us who they are, where they are or what they're making."
"Moreover, we believe that presently, there are hundreds of other firms operating as compounding pharmacies, producing what should be sterile products and shipping across state lines in advance of or without a prescription," Woodcock added in her testimony. "However, the current legal framework does not provide FDA with the tools needed to identify and adequately regulate these pharmacies to prevent product contamination."
And even when FDA has the authority to go after some types of compounders, such as those operating at large scale and producing products in advance of receiving a prescription as required by law, Woodcock said it's not always desirable to go after those facilities given their status as major drug suppliers to hospitals around the country. "A shut-down at these firms is likely to cause disruptions in the supply of drugs to hospitals and other health care providers," Woodcock explained. "FDA should have more tailored authorities appropriate for this type of compounding pharmacy."
Woodcock went on to support many of the authorities called for under the HELP legislative draft, calling in particular for greater regulatory authorities for FDA officials to be used to more tightly oversee the industry.
"Given our experiences over the past 20 years and the recent fungal meningitis outbreak, we must do everything we can to clarify and strengthen FDA's authority in this area," she concluded.