Pharmalot Blog--Ed Silverman-FDA Spars With Recalcitrant Compounding Pharmacy Over A Recall Posted Mon, 08/19/2013-8:15 am

Once again, the FDA is at loggerheads with a compounding pharmacy and the latest case underscores the difficulties the agency can sometimes encounter when trying to oversee a compounder that refuses to comply with enforcement steps.

Late last week, the FDA late last week took the unusual step of issuing a reminder to healthcare providers not to administer any sterile drugs made and distributed by NuVision Pharmacy. The agency issued a similar alert this past May and last month, sent a letterto the Dallas compounder requesting an immediate recall of all sterile products.

However, the compounder responded by issuing a statement on its web site maintaining that it does not qualify as a drug manufacturer and “current state laws do not require compounding pharmacies to follow (FDA) standards for manufacturing.” And NuVision added that it is not issuing a recall for all products, and the FDA maintains it cannot require the compounder to do so.

Last April, the agency issued an alert to healthcare providers, hospitals and pharmacies over concerns that freeze-dried powder drugs held a “high potential” for contamination based on an ongoing inspection. At the time, NuVision agreed to recall those particular products, but in its July 26 letter, the FDA notes that NuVision failed to address sterility problems seen during an inspection last March (here is the report).

The FDA is likely to point to this battle as an example of why Congress needs to pass legislation that would clarify and enhance its authority over compounders. The issue arose in the wake of an outbreak of fungal meningitis traced to the New England Compounding Center in which 749 cases, including 63 deaths, have been reported in nearly two dozen states (see this).

The episode has cast a harsh spotlight on the FDA and state regulators, and the extent to which they properly exercise their available authority. There has been considerable debate over this point, especially since FDA officials earlier this year acknowledged that more could have been done to oversee compounders (see this).

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Is It Time To Overhaul The FDA? A Panel With Pharmalot Posted Tue, 06/18/2013 - 9:01am by Ed Silverman 0

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Ed Silverman Pharalot Blog: FDA Begins Crackdown On "Risky" Compounders

In the wake of the scandal over the fungal meningitis outbreak, the FDA last month began a new crackdown on compounding pharmacies that is targeting about 30 so-called ‘high risk’ operations in nearly a dozen states and late last week disclosed that inspections reports were issued for four compounders for a variety of serious manufacturing violations.

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Ed Silverman's Pharmalot blog-What’s Not To Like? Facebook And The FDA

• Pharma Blog » 2013 » February » 27

Last month, the FDA tagged a dietary supplement maker for a laundry list of infractions, but one item tucked away in a December 11 warning letter stands out. The agency complained to Amarc Enterprises that one of its products was ‘liked’ last year on its Facebook page. This was cited as one example of numerous testimonials that could be construed as claims that cause the Poly MVA supplement to be considered a drug. - See more at: http://www.pharmalot.com/2013/02/whats-not-to-like-facebook-and-the-fda/#sthash.ewA1JpWz.dpuf

Ed Silverman Pharmalot post: An FDA Seal Of Approval To Prevent Shortages?

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Massachusetts Tries To Get Tough With Compounders--Ed Silverman's Blog

By Ed Silverman // January 7th, 2013 // 8:59 am

In the wake of the fungal meningitis scandal that regulators have traced to the New England Compounding Center, Massachusetts Governor Deval Patrick late last week proposed new laws in hopes of preventing another debacle. So far, the outrbreak has led to 656 cases and 39 deaths in 19 states (see this and this).

The move comes amid an embarrassing episode for both state health authotiries and the FDA, which have offered confusing explanations about their failure to follow up early indications that the compounder had committed various infractions. The ensuing ruckus has led to congressional probes in the proper role regulators are expected to play.

The new Massachusetts legislation would create strict licensing requirements for compounding sterile drugs; allow the state to assess fines against pharmacies; establish whistleblower protections for compounding pharmacy employees, and reorganize the state pharmacy board to include more members who are independent of compounders.

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What Did FDA Miss At New England Compounding?

By Ed Silverman

 Two months ago, the FDA inspected the New England Compounding Center, the pharmacy that has been linked to 590 cases of fungal meningitis, including 37 deaths (see this), and found a variety of disturbing conditions. These included ‘greenish-black foreign matter’ on sterilization equipment and air conditioning that was turned off each night despite the need to control room temperatures (back story with link to FDA report).

Similarly, the Massachusetts Department of Public Health conducted its own inspection in October and ran across some of the same things, such as a leaking boiler adjacent to the a clean room and wet floor surfaces, including a “tacky mat” that were soiled with black debris (here is the state report).

Nonetheless, more than a dozen people who have filed federal lawsuits against the NECC, which is located alongside a recycling plant that is owned by one of the two individuals who also run the compounder, received permission from a judge to conduct their own inspection (here is the order). Why? The plaintiffs believe the regulators may have missed some important pieces of evidence.

In an affidavit filed in the litigation, Tom Irmiter of Forensic Building Science, who has been retained by the plaintiffs to conduct the inspection, maintains there is no evidence that the FDA and state inspectors examined the overall condition of the building as a potential contributor to the contamination. And so he proposes to dissect the walls, ceiling, roof and foundation (here is the affidavit).

“Here’s an entity undergoing tremendous turmoil. We believe the preliminary (state) report that was issued is missing some things that may yield some other signs,” says Mark Zamora, an attorney for Chad Green, who claims he developed a joint infection and abscess due to an NECC medicine. “The FDA conducted testing of the vials, a baseline test for contaminants in May and released an eight-page inspection and observation report, which I think candidly revealed an overwhelmed agency struggling to come with an outbreak.

“But no one has access to raw data and we think they missed some things. For example, the garbage dump is yards from the facility. They didn’t examine the HVAC. We’re concerned with what may be found in the clean room. I think they did a decent job of explaining source contamination of product itself. But for us, we want to know how how did the material get in the vials? And if it’s the vial, did it come from the company that supplied the product or from the company that made the finished product?”

Such a move is predictable, but could also yield some interesting clues that might underscore the need for modifying regulatory inspections. As the attorney notes, the existence of contamination is obviously a key element of any inspection, but learning how the contamination occurred is equally crucial. A leaky boiler and the failure to use air conditioning may have been culprits here, but maybe there is more to the story.

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Ed Silverman's Blog--KV Pharma Loses Another Battle Over Makena

Ed Silverman states at his Pharmalot blog on 1/4/13:

KV Pharmaceutical may have emerged from bankruptcy in hopes of marketing still more of its controversial Makena treatment for reducing the risk of premature births. But the troubled little drugmaker, which has consistently locked horns with the FDA, last week lost another battle with the agency over its efforts to fend off competition to its controversial drug.

This time, the FDA rejected a petition KV had filed in hopes of preventing agency approval of a generic version of Delalutin, an older version of Makena, or hydroxyprogesterone caproate. KV argued that the FDA should not approve a generic because this would violate its exclusive marketing rights for Makena under the Orphan Drug Act (here is the petition).

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Ed Silverman is Reporting that Compounding Owners Fail Another FDA Inspection

To read his breaking news reported at the Pharmalot blog regarding Alaunus Pharmaceuticals click here