Recalled Meds Found in N. Prov. Spa | WPRI.com

Recalled Meds Found in N. Prov. Spa | WPRI.com

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.
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Official: Meningitis outbreak could have been prevented

December 5, 2012

Official: Meningitis outbreak could have been prevented

By Matt Murphy 
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

 

F.D.A. Finds Safety Problems at Company Supplying Drugs

21 hours ago by editor 0

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.