What Proposed Federal Legislation IS Meant To Do?

VALID Compounding Act will give FDA authority it needs to ensure the safety of the compounding pharmacy sector nationwide

WASHINGTON, D.C. – Today, Congressman Edward J. Markey (D-Mass.) announced legislation he plans to introduce tomorrow that will strengthen federal regulations for compounding pharmacies. The New England Compounding Center (NECC), a compounding pharmacy located in Rep. Markey’s Congressional District, has been found to be the source of contaminated injectable steroids that have led to 28 deaths and 377 illnesses in 19 states. The Verifying Authority and Legality in Drug (VALID) Compounding Act will give the Food and Drug Administration (FDA) clear, new authority to oversee compounding pharmacy practices throughout the country.

“Compounding pharmacies have been governed by fragmented regulations for too long, leading to the worst public health disaster in recent memory,” said Rep. Markey, senior member of the Energy and Commerce Committee. “The VALID Compounding Act ends this regulatory black hole by giving the FDA new, clear authority to protect patients and oversee these companies. I look forward to working with my colleagues in Congress on a bipartisan basis to move this legislation forward.”

A copy of the VALID Compounding Act can be found HERE. A one-page description of the legislation can be found HERE.

The VALID Compounding Act will:

• Preserve state regulatory authority for traditional small compounding pharmacy activities;
• Ensure that compounding pharmacies that are operating as drug manufacturers are regulated by the FDA as drug manufacturers;
• Allow compounding pharmacies with a legitimate reason to compound drugs before the receipt of a valid prescription to request a waiver to enable them to do so;
• Allow the FDA to waive the requirement to compound drugs solely for individual patients with valid prescriptions in the event of a drug shortage or to protect public health;
• Allow the FDA to waive the requirement to compound drugs only if they are not copies of commercially-available drugs if doing so is necessary to protect public health or well- being; and
• Increases transparency to the public by mandating that compounded drugs be labeled to ensure that recipients know that the drugs have not been tested for safety or effectiveness, publishing a “Do Not Compound” list of unsafe or ineffective drugs, and reporting of bad reactions to compounded drugs or any drug that poses a safety risk.

“This bill will save lives by ensuring that compounding pharmacies play by the rules that are essential to protect patients,” said Diana Zuckerman, PhD, president of the Cancer Prevention and Treatment Fund. “This month’s tragic meningitis outbreak from contaminated steroid injections was absolutely preventable. We call on Congress to work in a bipartisan manner to pass Congressman Markey’s legislation, which is necessary to protect our families from these predictable, preventable tragedies.”

The legislation has been endorsed by Cancer Prevention and Treatment Fund, Jacobs Institute for Women’s Health, National Consumers League, National Research Center for Women & Families, Our Bodies Ourselves, and Union of Concerned Scientists. A copy of the endorsement letter can be found HERE.

Earlier this week, Rep. Markey released the report “Compounding Pharmacies, Compounding Risk”, which revealed that even before the current outbreak, problems at compounding pharmacies led to at least 23 deaths and 86 illnesses in 34 states, and that state regulatory bodies typically focus on more non-safety related traditional pharmacy licensing activities. A timeline of Rep. Markey’s work on compounding pharmacies can be found HERE.

Source found here

Valid Compounding Act--To Be Introduced Into Federal Legislation Tomorrow

To view the proposed bill, click here

Markey's Legislation to Be Introduced Friday and To be FDA-Regulated if Large Producers

Under Markey’s legislation, to be introduced Friday, such pharmacies would be FDA-regulated, if they produce larger quantities of a drug for general distribution. Officials say that’s what the company appeared to be doing, though they were only permitted to produce patient-specific prescriptions.

The bill also requires pharmacies to label compounded drugs to show they haven’t been FDA-tested.

Source found here

Mass. lawmaker seeks greater pharmacy regulation

By JAY LINDSAY

Associated Press / November 1, 2012

 FRAMINGHAM, Mass. (AP) — A Massachusetts lawmaker says he'll introduce legislation to increase federal oversight of specialty pharmacies like the one linked to a deadly meningitis outbreak.

Democratic U.S. Rep. Ed Markey made the announcement Thursday outside the now-closed New England Compounding Center in Framingham.

A tainted steroid made by the center caused a fungal meningitis outbreak linked to 28 deaths across the country.
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Pharmacy Compounding: Federal Law in Brief

by Jonathan J. Darrow

Until recently, most ordinary people had never heard of “pharmacy compounding.”  Then, a number of deaths and illnesses caused by a drug that was compounded in a Framingham, Massachusetts pharmacy propelled drug compounding to the national spotlight (see, e.g., Denise Grady et al., Scant Oversight of Drug Maker in Fatal Meningitis Outbreak, N.Y. Times, Oct. 6, 2012).

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FDA & Compounders: More Oversight Needed?

1 day ago by editor
By Ed Silverman

ver the past two years, compounded medications have figured in two highly controversial episodes. In one instance, Roche attempted to prevent ophthalmologists from using its older Avastin med for treating wet macular degeneration when its newer and more expensive Lucentis is the only approved treatment. The drugmaker has claimed that rejiggered vials of Avastin pose a safety risk (readhere and here).

In another, KV Pharmaceutical caused a huge ruckus by initially charging $1,500 for its Makena premature birth drug and trying to use its FDA approval under the Orphan Drug Act to prevent compounding pharmacies, which charged a fraction of the price, from competing. The move outraged physicians, among others, who maintained the compounded versions were safe and kept a lid on rising healthcare costs.

Now, an outbreak of meningitis that has been traced to a compounding pharmacy in Massachusetts has, once again, placed compounding in the spotlight, and renewed debate about the extent to which oversight is sufficient. The outbreak, which has left five people dead and another 30 in various stages of illness across six states, appears to have been caused by a compounded steroid drug contaminated by a fungus.

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The Sound of Silence

LINDA GREENHOUSE October 31, 2012, 9:00 PM

Reading about the belated scramble by Massachusetts regulators toinspect the compounding pharmacies in their state in the wake of the meningitis crisis left me wondering about the apparent lack of federal oversight of the $3 billion

Markey to unveil plan sparked by deaths linked to Framingham lab

Markey to unveil plan sparked by deaths linked to Framingham lab

Mass. to Hold Hearings on State Health Department

November 1st, 2012

BOSTON (AP) — Massachusetts lawmakers are planning to announce a series of public hearings looking into the state Department of Public Health’s handling of two recent crises.

The first hearing will look at the department’s oversight of pharmacies in Massachusetts.

The hearing comes in the wake of a deadly fungal meningitis outbreak linked to a compounding pharmacy in Framingham that has sickened 377 nationwide, 29 of whom have died.

The second public hearing will look at the department’s supervision of the state drug laboratory following the testing scandal at the drug lab.

A third public hearing will look at the state’s role in overseeing the department and the need for increased transparency at the department.

State Reps. Jeffrey Sßnchez, David Linsky, and Harold Naughton plan to announce the hearing schedule Thursday at the Statehouse.

Source found here

Huge Drug Recall Latest Fallout in Meningitis Outbreak

By Sharon Begley | November 1, 2012

Ameridose, a sister company of the U.S. pharmacy linked to a meningitis outbreak that has killed 29 people, announced on Wednesday a voluntary recall of all its products, a move to cooperate with regulators that could nevertheless create shortages of some drugs.

In particular, the U.S. Food and Drug Administration and a number of hospitals are concerned about the availability of several drugs for which Ameridose has been a major supplier, including those given as shots or intravenous drips or used during surgery.

The Westborough, Massachusetts-based company, which was closed on Oct. 10, said it had not received any reports of adverse reactions to the products it is recalling but that the FDA has asked it to improve its sterility testing processes.

“Ameridose and FDA agree that the use of injectable products that are not sterile can represent a serious hazard to health,” the company said in a statement, adding that it shipped its medications nationwide.

The company asked its customers to quarantine Ameridose drugs while they arrange to return them to the company.

Earlier in October, the FDA said, “The current production shutdown of Ameridose may impact supplies of certain drugs for some health care systems.”

The FDA “is aware that this recall might affect the availability of certain drugs,” Dr. Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, told Reuters. “This is a company that produces and ships a lot of sterile injectables. We are trying to mitigate the effects (of the Ameridose recall) on drug supplies.”

FILLING THE GAP

The FDA has already spoken with other manufacturers about filling the supply gap left by the shutdown of Ameridose and now the recall of its products, Woodcock said, including helping those whose manufacturing facilities have been curtailed by technical or other issues “get back into production.”

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