Thursday, December 6, 2012
A Compounding Fracture at the FDA
The agency has been slow to exercise control over pharmacies that mass produce drugs.
The recent deadly outbreak of meningitis caused by spinal injections of a contaminated steroid has cast a spotlight on the practice of pharmacy compounding—when pharmacists mix or adapt medicines to make a specific prescribed treatment. The House and Senate are holding oversight hearings this week on the tragedy that has sickened at least 438 people and is believed to have killed more than 30.
Congress wants to know why the Food and Drug Administration didn’t do more to prevent the production and sale of tainted steroids by the New England Compounding Center. The FDA will likely say that it doesn’t have enough authority to regulate the pharmacies that compound drugs.
But the FDA does have enough authority. And it did in 2006, when the agency sent a warning letter to the New England Compounding Center, in effect telling the NECC to stop manufacturing certain drugs or face legal action. In 2006, the warning came because the compounding pharmacy was, among other things, violating regulatory rules by producing drugs that were already commercially available from FDA-approved manufacturers. Six years later, NECC was not only still operating but also, it has become clear, selling tainted drugs. Where was the FDA? What was the problem?
The trouble didn’t come from traditional compounding, which is a legitimate part of the practice of pharmacy. Compounding pharmacies mix or alter drug ingredients to adapt a medicine based on a doctor’s prescription—for example by changing a pill into a formula, tailoring chemotherapy, or adding cherry flavoring to a child’s medicine. The practice lets physicians customize drugs to individual patients. Traditional pharmacy compounding typically is performed on a small scale and is always performed in response to a valid prescription.
The FDA normally doesn’t get involved with such practices because it isn’t tasked with regulating the legitimate practice of pharmacy. Like the practice of medicine, pharmacy is largely left to professional and state oversight. But once pharmacies begin manufacturing and shipping medicines on a mass scale, they become “drug manufacturers” and fall squarely under the FDA’s extensive authority.
There are unambiguous rules governing when a compounding pharmacy crosses the line and becomes subject to FDA supervision. The practice of compounding, for example, does not allow the manufacture of copies (or near copies) of FDA-approved drugs that are commercially available. By all accounts, the New England Compounding Center was hardly a pharmacy as generally understood; it was manufacturing unapproved duplicates of FDA-approved drugs and distributing them for a large-scale market without first receiving valid prescriptions for the individual drugs.
This all put the NECC firmly in violation of FDA rules—if the agency had chosen to enforce existing provisions. But in recent years the FDA has seldom drawn clear lines between practices that are legal and beyond its purview and ones over which it clearly has authority. The regulatory hesitation has meant that some of the shadiest compounding outfits haven’t been reined in. And it magnified risks by emboldening more pharmacies to go well beyond traditional compounding and engage in large-scale drug making—because it seemed a fairly safe bet that the FDA wouldn’t come knocking.
Meanwhile, the agency has been focused on enforcement activity that could instigate legal showdowns and set judicial precedents that would expand FDA power over the full scope of the practice of pharmacy. Part of this strategy is philosophical: Many at the agency have long believed that all of the professional practice of pharmacy belongs under the FDA’s oversight. Then there is regulatory languor: The FDA reasons that if it can assert jurisdiction over the entire profession, then it can more easily pick and choose where to focus its energies, instead of having to establish in advance which firms are crossing the line.
Take, for example, the FDA’s recent (and unsuccessful) enforcement action against the compounding firm Franck’s Pharmacy, a maker of customized veterinary drugs. Rather than allege that Franck’s had crossed the line from traditional pharmacy compounding to drug manufacturing, the FDA took the expansive position that it had the authority to regulate the practice of pharmacy in general and traditional pharmacy compounding in particular. The federal judge overseeing the Franck’s case easily rejected FDA’s power grab (although the judge didn’t dispute, and specifically noted, that the FDA has the authority to regulate drug manufacturing carried out under the guise of traditional compounding).
Ironically, the FDA is now using legal defeats like the one in the Franck’s case as the excuse for why it couldn’t be tougher on the steroid-maker NECC. This week, the FDA will ask Congress for new authorities to expand its oversight over the practice of pharmacy.
Instead, Congress should instruct the agency to issue regulations that assert the authorities that the FDA already has—drawing a bright line between the traditional practice of pharmacy (regulated by states) and the place where a compounder has crossed the line into drug manufacturing, making itself subject to federal regulation.
The FDA has failed for decades to clearly establish enforcement policies related to pharmacy compounders because the agency doesn’t want to concede that it was never supposed to have jurisdiction over the legitimate, local practices of pharmacy and medicine. In the process, the agency has undermined its own mission.
Dr. Gottlieb, a resident fellow at the American Enterprise Institute, was deputy commissioner of the FDA from 2005-07. Mr. Bradshaw was the FDA’s chief counsel from 2005-07. He was retained by Franck’s Pharmacy as an expert witness in the FDA case against the company.
A version of this article appeared November 14, 2012, on page A15 in the U.S. edition of The Wall Street Journal, with the headline: A Compounding Fracture at the FDA.
Source found here
American College of Veterinary Pharmacists Basic Veterinary Compounding Course 1/7-8/2013
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STATE OF WISCONSIN Board of Pharmacy
will discuss Federal Letters Requesting State Information as it Relates to Compounding Pharmacies at the next board meeting on December 12, 2012. See here
GAP Sues FDA for Wrongful Withholding of Animal Drug Data
The Food and Drug Administration's decision to withhold agency data regarding the sale of antibiotics for use in food animals is unlawful, the Government Accountability Project (GAP) said in a lawsuit filed today. Read article here
druganddevicelaw: Second Circuit Reverses Off-Label Promotion Conviction On First Amendment Grounds
Monday, December 03, 2012
Second Circuit Reverses Off-Label Promotion Conviction On First Amendment Grounds
The long wait is over. Here is the Second Circuit's decision in United States v. Caronia, No. 90-5006-cr, slip op. (2d Cir. Dec. 3, 2012). By a 2-1 vote, Mr. Caronia's conviction for off-label promotion is reversed on First Amendment grounds. The ruling is unmistakable. There was no question that off-label promotion had occurred. Slip op. at 14-16. The sole basis for vacating the conviction was the government's failure to prove that any of the alleged promotion was false.
off
Interestingly, even the government tried to run for cover from the First Amendment, arguing on appeal that off-label promotion only "plays an evidentiary role" in a criminal prosecution for misbranding. Slip op. at 27 (emphasis original). Thus:
The government contends that Caronia was not prosecuted for his speech, but that Caronia's promotion of [an] off-label use served merely as “evidence of intent,” or evidence that the “off-label uses were intended ones[] for which [the drug’s] labeling failed to provide any directions.”
Id.
The majority in Caronia didn't buy the change of tactics. "[T]hat is not what happened in this case." Id. at 28.
Continue reading here
Second Circuit Reverses Off-Label Promotion Conviction On First Amendment Grounds
The long wait is over. Here is the Second Circuit's decision in United States v. Caronia, No. 90-5006-cr, slip op. (2d Cir. Dec. 3, 2012). By a 2-1 vote, Mr. Caronia's conviction for off-label promotion is reversed on First Amendment grounds. The ruling is unmistakable. There was no question that off-label promotion had occurred. Slip op. at 14-16. The sole basis for vacating the conviction was the government's failure to prove that any of the alleged promotion was false.
off
Interestingly, even the government tried to run for cover from the First Amendment, arguing on appeal that off-label promotion only "plays an evidentiary role" in a criminal prosecution for misbranding. Slip op. at 27 (emphasis original). Thus:
The government contends that Caronia was not prosecuted for his speech, but that Caronia's promotion of [an] off-label use served merely as “evidence of intent,” or evidence that the “off-label uses were intended ones[] for which [the drug’s] labeling failed to provide any directions.”
Id.
The majority in Caronia didn't buy the change of tactics. "[T]hat is not what happened in this case." Id. at 28.
Continue reading here
Official: Meningitis outbreak could have been prevented
December 5, 2012
Official: Meningitis outbreak could have been prevented
By Matt Murphy
State House News Service
State House News Service
---- — BOSTON — As the state’s pharmacy board considers final regulations to improve oversight of retail and compounding pharmacies, some in the industry believe it was the lack of enforcement of existing rules that led to a deadly fungal meningitis outbreak.
“In retrospect, we feel this situation could have been prevented if either the FDA or the Board of Pharmacy enforced the regulations already on the books,” Todd Brown, executive director of the Massachusetts Independent Pharmacists Association, told the News Service yesterday after testifying before the board.
Brown and David Miller, of the International Academy of Compounding Pharmacists, offered feedback yesterday to the Board of Registration in Pharmacy on emergency regulations put in place Nov. 1 following the linkage of the meningitis outbreak to tainted steroids produced by the New England Compounding Center in Framingham.
Only three people testified on the regulations that apply to an industry that has come under scrutiny in Massachusetts and at the federal level in the wake of the outbreak.
Brown called it “ironic” that a Massachusetts pharmacy would be responsible given the relatively strict regulations already in place, and he called NECC an “outlier” that flaunted the state’s regulations and yet their violations went undetected.
Board president James DeVita and counsel Heather Engman alone were on hand to collect public comment on the regulations adopted at the direction of Gov. Deval Patrick in early November. The state at that time also permanently revoked NECC’s pharmacy license and Patrick established a special commission to report back before the end of the year on legislative steps the state could take to improve its oversight and pharmacy licensing laws and regulations.
The board also began periodic, unannounced inspections of compounding labs in the state.
While the regulations governing Massachusetts-based pharmacies are already strong, according to Brown and Miller, both said they had concerns that there was no registration process for out-of-state pharmacies doing business in Massachusetts. Georgia and Pennsylvania are the only other two states that don’t require out-of-state registration.
“It is a concern to us whenever we see a board that doesn’t have the same type of protections for citizens of pharmacies and compounding pharmacies outside its borders,” Miller said.
Brown said he has been in contact with legislators who have agreed to file legislation regarding the registration of out-of-state pharmacies in Massachusetts, though he declined to name lawmakers with whom he has been working.
Miller also raised concerns about the amount of time allowed before a pharmacy shut down by the board can have a hearing. The emergency regulations specify that a pharmacy is entitled to a hearing within 21 days of receiving a cease-and-desist order, but Miller said that could be very detrimental to both the business and patients looking to get their prescriptions filled. He recommended holding a hearing within five days.
“We’re placing our patients at risk with not being able to obtain their medications,” Miller said.
The emergency regulations adopted by the board require compounding pharmacies to report to the state the volume and distribution of drugs to determine whether they are acting more like a manufacturing facility that would be subject to Food and Drug Administration oversight.
The regulations also require pharmacies to report to the state when they are the subject of an investigation by another state or federal authority, and create stiffer penalties if pharmacies fail to comply with rules and regulations.
Brown suggested clarifying the definition of compounding, and limiting the requirement that pharmacies report “adverse events” to the state to those associated with compounding or when compounding products cause serious harm attributed to the accuracy, potency or sterility of the product.
Paul Garbarini, a pharmacist and attorney who represents pharmacies sanctioned by the board, also took issue with the requirement that pharmacists report pending criminal charges to the board.
“I think it flies in the face of common sense and fair play,” he said, suggesting convictions would be more relevant.
Source found here
Wednesday, December 5, 2012
F.D.A. Finds Safety Problems at Company Supplying Drugs
By DENISE GRADY and SABRINA TAVERNISE
A federal inspection has turned up a long list of unsanitary conditions and unsafe practices at Ameridose, a drug supplier with some of the same owners as the pharmacy whose tainted steroid caused a nationwide outbreak of fungal meningitis that has killed 32 people and sickened more than 400 others.
A 20-page report issued on Monday by the Food and Drug Administrationdescribed drug solutions contaminated with germs, rusted and unsanitary equipment, and insects and a bird flying around in areas where sterile products were packaged and stored.
Inspectors also said the company failed to “adequately investigate” complaints of serious reactions in patients that might have indicated problems with drug potency — reactions including fetal distress, a hyperstimulated uterus and maternal hemorrhaging from a drug used in labor, and oversedation and breathing trouble from fentanyl, a powerful narcotic. There were also complaints of low potency in a sedativeused to relieve anxiety in children undergoing surgery.
“F.D.A. inspectors observed conditions and practices at Ameridose which demonstrated that the firm could not consistently assure that their injectable products were sterile and safe for use by patients,” Sarah Clark-Lynn, a spokeswoman for the agency, said in an e-mail.
So far, Ms. Clark-Lynn said, no infections have been linked to Ameridose, but all its products have been recalled, and its operations have been suspended since early October at the request of state regulators, who say they need more time to investigate.
Ameridose said in a statement that it had had no instances of product contamination in its six-year history, during which it had shipped “70 million units of product.” However, problems with potency did result in at least one recall. The company said it was “committed to addressing all observations in order to enhance our existing systems.”
Eric S. Kastango, the president of Clinical IQ, a consulting firm that advises compounding pharmacies, said the F.D.A. findings at Ameridose were “just stupefying.”
“It’s an operation that is totally out of control,” he said. “Especially when you look at the patient complaints, that is scary as all get-out.”
Ameridose has been a major supplier of sterile injectable medications to hospitals and sells more than 2,200 blended drug products, including tranquilizers, anesthetics andantibiotics, according to its Web site.
The inspection report dealt another blow to the family behind Ameridose and its sister company, the New England Compounding Center, which made the fungal-tainted steroid medication that caused the meningitis outbreak. The report comes just two days before the House Committee on Energy and Commerce is scheduled to hold a hearing on the outbreak. Barry Cadden, the chief pharmacist at the New England center, was subpoenaed by the committee after he declined its initial request to testify. Federal officials have said Ameridose was investigated because of concerns that it had some of the same business practices as New England Compounding.
Ameridose, founded in 2006, is a private company and is not required to report its financial status publicly. Weeks of no activity seem to have taken their toll on the company, which has laid off or furloughed most of its 650 employees, as well as 140 employees of its sales affiliate, Medical Sales Management.
Ameridose was founded by the same people who owned the New England Compounding Center — Mr. Cadden, who has since lost his license; Gregory Conigliaro, a businessman; and Mr. Conigliaro’s sister-in-law, Carla Conigliaro. It is based in Westborough, Mass.
Robert C. Coleman, a retired F.D.A. investigator, said in an e-mail that while the inspection report was not the worst he had seen, “I would not want to use any of the company’s products.”
Mr. Kastango said part of the problem was that Ameridose, while run by pharmacists, had become a major drug manufacturer, without the proper procedures for safe mass production.
“It’s just unfathomable that they were able to operate for as long as they did,” he said, adding that he doubted Ameridose would ever be able to open for business again.
Andrew Pollack contributed reporting.
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