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Friday, November 2, 2012
VALID Compounding Act to regulate compounding pharmacies is introduced
November 02, 2012
A new policy debate over drug regulation is emerging as the
NECC scandal worsens
As
promised, US Rep. Edward Markey (D-MA) has introduced legislation,
provisionally called the Verifying Authority and Legality in Drug (VALID)
Compounding Act, in an attempt to clarify the distinction between pharmacies
that compound drugs for individual patients (a very common practice) and those
that perform compounding on a scale that makes them, in effect, drug
manufacturers. The bill is a response to the widening scandal over contaminated,
compounded steroid preparation that has (as of Oct. 31) led to the deaths of 28
and meningitis infection of 377 patients. New England Compounding Center
(Framingham, MA; the company is in Markey’s Congressional district) produced
around 17,000 dosages of the drug, methylprednisolone acetate, in early summer;
the three lots of the compounded drug have now been recalled (along with other
products of NECC) and the plant is shuttered.
Meanwhile, the Massachusetts state government has issued emergency rules to
require compounding pharmacies to report volumes of drugs so produced, and to
report to the state when other states are investigating a pharmacy’s products.
It has also set up a commission to develop a report to the governor by year-end.
“The compounding industry has evolved, and in some ways it has outgrown the
current regulatory framework, not just the state but the federal regulatory
framework,” said Governor Deval Patrick, according to a Boston Globe report.
The VALID Act specifies that compounded drugs be labeled as such (and with
the notation that the drug has not been approved by FDA), and clarifies, to some
degree, the distinction between pharmacies compounding drugs for individual
patients (which has been and will continue to be under state regulatory
authority) and those who are effectively engaged in manufacturing. The Secretary
of HHS is to provide a list of drugs that are not to be compounded; and to
prohibit the copying of commercially available drugs. A set of waivers allowing
production of compounded product without individual prescriptions, and of
certain types of pharmacies (such as those at hospitals) is also
specified.
It’s not clear to what extent Markey’s proposed legislation would change
the existing circumstances, except perhaps that physicians and patients are
better informed that a compounded product is being dispensed. But even in that
case, would a patient reconsider taking a drug that a physician is recommending?
FDA already has authority to regulate what it believes to be manufacturers—but
that authority has been under steady attack by trade associations affiliated
with compounding pharmacists. Finally, FDA itself authorized the compounding
(or, to be precise, announced that it did “not intend to take enforcement action
against pharmacies” involved in the activity) of hydroxyprogesterone caproate,
when KV Pharmaceuticals won approval to market that compound as a branded
product, Makena, in 2011. KV (which is now in bankruptcy proceedings) intended
to sell the drug for roughly $1,500 per injection, while the compounded
product had been available for around $20.
Several trends are going to drive this debate: the heightened focus on using generic drugs as a cost-saving measure by health systems; the twists and turns that “personalized” medicine is taking—including bringing consumer interests and preferences into drug-dispensing decisions; and the intensifying push by pharmacists’ business and professional associations to have a greater say in prescribing practices. The ongoing drug-shortage problem has also played into this growing debate, as there are indications that a backup for some drugs in short supply has been to compound the product to address immediate needs (Markey’s bill specifies a waiver for “when necessary to protect public health”).
Source found here
Meningitis outbreak nears 400 infected as lawmakers push for tougher regulation
More than 400 infections have now been tied to an outbreak linked to contaminated steroid shots from the New England Compounding Center, the Centers for Disease Control and Prevention announced Friday.
Is meningitis in your state?
The ongoing 19-state outbreak of fungal meningitis has been linked back to three lots of methylprednisolone acetate (MPA) steroid injections made by the Compounding Center of Framingham, Mass. The injections were shipped to 23 states and officials have said up to 14,000 patients may have received the contaminated shots, mostly for back pain treatments.
- Ameridose, company linked to New England Compounding Center, issues recall
- FDA finds contaminated vials, bacteria and mold at New England Compounding Center
- FDA: Bacteria found in other drugs made by New England Compounding Center
The agency said the findings bolster concerns about a lack of sterility at the now-closed company. Investigators there have already found standing water from a leaking boiler, filthy floor mats and records indicating drugs were shipped before sterility tests were returned.
Continue reading here
Meningitis-Related Pharmacy Recall Worsens Drug Shortage
By Anna Edney - Nov 2, 2012
The recall of hundreds of drugs by Ameridose LLC, a compounding pharmacy associated with the U.S. meningitis outbreak, may be exacerbating shortages of medicines used for surgery and heart failure, regulators said.
The recall of hundreds of drugs by Ameridose LLC, a compounding pharmacy associated with the U.S. meningitis outbreak, may be exacerbating shortages of medicines used for surgery and heart failure, regulators said.
The Food and Drug Administration is working with other
manufacturers to ramp up production and may consider foreign suppliers,
Commissioner Margaret Hamburg said in a Web posting
today. The drugs Westborough, Massachusetts-based Ameridose made were already in
short supply and include local anesthesias, muscle relaxers to prevent movement
during surgery and high-dose diuretics to remove fluids during congestive heart
failure.
Continue Reading here
FDA: 2 More NECC Drugs Contaminated
ByDaniel J. DeNoon
WebMD Health NewsNov. 1, 2012 -- Two more drugs made by the New England Compounding Center (NECC) are crawling with various kinds of bacteria, FDA tests reveal.
Tests of each lot of the drugs found a different combination of bacteria:
Two of these bacteria -- Bacillus idriensis and Bacillus circulans -- have been linked to rare cases of human disease. The FDA says that for patients treated with these drugs, "the clinical significance of these results is not known."
All NECC drugs were recalled on Oct. 6. The FDA has not estimated how many patients were treated with the contaminated betamethasone or cardioplegia solution before that date.
So far, the CDC has not received any reports of laboratory-confirmed bacterial infections linked to these NECC products.
As of today, there have been 377 cases of fungal meningitis and nine cases of fungal joint infections in people who received NECC drugs. Twenty-eight of these people have died.
Source found here
WebMD Health NewsNov. 1, 2012 -- Two more drugs made by the New England Compounding Center (NECC) are crawling with various kinds of bacteria, FDA tests reveal.
The NECC is the Massachusetts compounding pharmacy whose drugs are the likely source of the ongoing outbreak of fungal meningitis. The FDA previously found fungus growing in unopened vials of the company's methylprednisolone injectable steroid.
Now the FDA has found bacteria in three lots of the NECC's betamethasone, another injectable steroid, and in cardioplegia solution, a drug used to stop the heart during transplant operations. It's not yet clear whether the drugs also carry fungal contamination or other kinds of bacteria.Tests of each lot of the drugs found a different combination of bacteria:
| Product and Lot Number | Microbial Identification |
| Betamethasone 08202012@141 | Paenibacillus pabuli/amolyticus, Bacillus idriensis, Bacillus flexus, Bacillus simplex, Lysinibacillus sp. |
| Betamethasone 07032012@22 | Bacillus niabensis, Bacillus circulans |
| Betamethasone 07302012@52 | Bacillus lentus, Bacillus circulans |
| Cardioplegia solution 09242012@55 | Bacillus halmapalus, Brevibacillus choshinensis |
All NECC drugs were recalled on Oct. 6. The FDA has not estimated how many patients were treated with the contaminated betamethasone or cardioplegia solution before that date.
So far, the CDC has not received any reports of laboratory-confirmed bacterial infections linked to these NECC products.
As of today, there have been 377 cases of fungal meningitis and nine cases of fungal joint infections in people who received NECC drugs. Twenty-eight of these people have died.
Source found here
Lawmakers want answers in meningitis outbreak
Lawmakers want answers in meningitis outbreak: TRIAD – Lawmakers on Capitol Hill want more details on the circumstances that led to a nationwide meningitis outbreak that killed 28 people, including a Denton woman, as a result of contaminated me...
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