Sixty-four people died and 750 more were sickened in 2012 by an outbreak of fungal meningitis from contaminated steroid injections, and Congress took action to prevent another such outbreak - but a top federal regulatory official has questioned whether the Drug Quality and Security Act goes far enough.
The outbreak was linked to the injectable steroids produced under what were supposed to be sterile conditions at the New England Compounding Center in Framingham, Mass. The compounder has been shut down and faces numerous lawsuits.
Signed by President Barack Obama on Nov. 27, the law creates a category for “outsourcing facilities,” which will supply large quantities of compounded pharmaceuticals to be used for patients at hospitals and clinics.
Three of Arkansas’ largest compounders have registered as outsourcers, among 24 nationwide as of Wednesday.
Under the new law, the federal Food and Drug Administration will have direct control over those compounders. The state boards of pharmacy will retain supervision over traditional compounders, which primarily prepare medications prescribed for individual patients.
Generally, compounders fill market needs when there are shortages from manufacturers.
The state boards’ authority over traditional compounders was clouded by a 2002 ruling by the U.S. Supreme Court. The Drug Quality and Security Act addresses that problem by removing obstacles raised in court cases, said Elizabeth Jungman, director of drug safety and innovation at The Pew Charitable Trusts.
Before the Drug Quality and Security Act was passed, some traditional compounders said, standards for large manufacturers were mistakenly applied to their operations, potentially placing undue burdens and costs on them, thus threatening their livelihoods.
One of them is Lee Pharmacy in Fort Smith.
The FDA inspected the pharmacy in early 2013 in the wake of the New England Compounding case - one of a number of inspections across the country.
The FDA and the Arkansas State Board of Pharmacy inspected Lee Pharmacy on the same day, Feb. 19, 2013. Federal inspectors found what they called seven areas of concern, according to federal documents. The state inspectors ranked the pharmacy as Class A, its highest rating.
The federal agency had sent the pharmacy a letter 10 years earlier about violations of the Food, Drug and Cosmetic Act. Lee Pharmacy corrected those problems, according to records.
The Arkansas Democrat-Gazette requested records last year on the matter under the Freedom of Information Act but has received nothing substantive on its disposition.
Meantime, Lee Pharmacy operates under the authority of the state pharmacy board, even if the FDA matter has not been resolved.
Owner Warren Lee said last week that business is good, and “I don’t see any cloud at all.”
While the Drug Quality and Security Act may lead to better regulation of compounding pharmacists, one of the FDA’s top officials expressed misgivings in a December teleconference with news media about the act’s limitations in regulating the new category of outsourcing facilities.
“It will be difficult for us to identify compounding pharmacies that choose not to register as outsourcers [and] then try to hide out ... as traditional compounders,” said Jane Axelrad, associate director for policy for the FDA’s Center for Drug Evaluation and Research, according to a transcript of the Dec. 2 teleconference.
The agency said in an email earlier this month in response to a question from the Arkansas Democrat-Gazette that because of the agency’s insufficient resources it will be able to do only “limited numbers of proactive inspections of … outsourcing facilities.”
The federal agency will have to rely on state pharmacy boards to notify the FDA about an “adverse event or quality complaint,” involving large compounders that don’t register as outsourcers.
That’s part of the new language in the law that is designed to clarify authority, said Allan Coukell, senior director for drugs and medical devices for Pew Charitable Trusts.
Among other things, the law calls for:
Compounders that make sterile drugs to register with the secretary of Health and Human Services.
Compounders to disclose to the Health and Human Services secretary any “adverse event reports.”
Health and Human Services to conduct inspections of outsourcing facilities.
State boards of pharmacy to inform the FDA of any disciplinary action against a compounding pharmacy.
Registration as an outsourcing facility is voluntary, but the law “has the potential to make a big difference for safety,” Coukell said. “It does depend on the purchasers and the market [along with effective oversight by the FDA and the boards of pharmacy] to make it work,” he said.
The Drug Quality and Security Act weathered criticism during a period of comment required before rules are implemented. The comment period ended Feb. 3. Implementation of regulations will occur sometime this year.
The International Academy of Compounding Pharmacists, which says it represents 3,600 pharmacists and others engaged in compounding, has issued a list of comments and suggestions.
In a Jan. 17 letter accompanying its critique of the draft guidance on the regulations, the academy accused the FDA of prematurely urging “stakeholders” - would be buyers of compounded medications, state government, state boards of pharmacy - to do business only with registered outsourcers, “when the FDA has not yet finalized guidance, restrictions, and quality standards for those … outsourcing facilities.”
Nevertheless, three Arkansas compounders - Cantrell Drug Co. and SCA Pharmaceuticals, both of Little Rock, and U.S. Compounding Inc. of Conway - registered as outsourcers in December.
For Cantrell Drug, becoming a registered facility is nothing really new, said owner Del McCarley. Cantrell Drug has been operating under the FDA’s “current good manufacturing practices” for about five years, he said.
“‘We’re just amending our registration” under the Drug Quality and Security Act, he said.
Marketplace demand from hospitals and clinics will drive compliance by the outsourcing facilities, McCarley said.
Cantrell Drug employs about 100 at its 20,000-squarefoot 7321 Cantrell Road facility, and plans to expand by another 50,000 square feet and add 100 to 200 employees within two or three years, McCarley said.
Until now, U.S. Compounding, which employs about 150, has operated only under the direct supervision of the state Board of Pharmacy.
Eddie Glover, chief executive of the U.S. Compounding, and Becca Mitchell, chief pharmacist and vice president of operations, were in Fort Lauderdale, Fla., earlier in February at the annual conference of the International Academy of Compounding Pharmacists. Glover has been a member of the academy board.
Mitchell acknowledged that there are a lot of questions to be answered but called the criticism of the law by the academy part of “a healthy dialogue.”
“My interpretation of IACP’s comments is there [are] still a lot of unknowns and that there are so many issues that are not clarified by this [law] and there are still a lot of questions remaining for FDA to answer and depending upon how FDA answers those, it may or may not protect patient access.”
“We are very, very strong members of IACP, and I don’t think that us registering has anything to do with IACP’s criticism of certain aspects of that [law]. U.S. Compounding is a pharmacy that bridges the gap when manufactured medication is in short supply and what patients, hospitals, physicians’ offices and surgeries need.
“It really was a no-brainer for us to register. We are under the impression that we will still be under the state board of pharmacy for certain aspects of our business.”
Glover said it is his opinion that the Massachusetts Board of Pharmacy was at fault in the New England Compounding incident. “That situation would never have happened in the state of Arkansas. We have a very proactive state board,” which has inspected “us on a regular basis.”
The National Association of Boards of Pharmacy has taken a more measured approach to the rollout of the new law. It “will be working closely with its member boards to ensure that all resulting regulations of the Act are in the best interest of the public health,” the group said in a Jan. 23 release.
Business, Pages 69 on 02/23/2014