Blumenthal Sends Letter To FDA Asking Why Agency Failed To Regulate Compounding Pharmacy That Manufactured Contaminated Drugs Found At Connecticut Hospital

(Washington, DC) – Today, U.S. Senator Richard Blumenthal (D-Conn.) sent a letter to U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg asking her to explain why the agency failed to regulate Med Prep Consulting Inc., a compounding pharmacy in New Jersey responsible for manufacturing contaminated drugs recently discovered by a nurse at Yale-New Haven Hospital in Connecticut. The contamination was determined to be mold, prompting a voluntary recall by the company. 
 
“This highly troubling incident highlights again the public health threats posed by compounding pharmacies – in this case, Med Prep Consulting Inc. – failing to provide safe pharmaceutical products and FDA failing to protect the public,”Blumenthal wrote. “I implore FDA to use the full extent of its regulatory and investigatory power to investigate Med Prep and stop dangerous practices both within the company and across the industry.” 

In 2001, FDA found that Med Prep was violating its regulations by using single-use vials of products more than once and failing to maintain master batch records for products, thereby compromising the sterility of the products. In response, FDA issued a Warning Letter asking the company what it would do to correct these actions.
 
In 2010, FDA issued another Warning Letter to Med Prep, informing the company that FDA found that Med Prep was engaging in repackaging behavior that is outside of the scope of the traditional practice of pharmacy.
 
“Now, in 2013, Med Prep has provided dangerously contaminated products clearly and imminently threatening public health and safety. This lifesaving discovery was made not by FDA inspection, but by watchful health care providers,” Blumenthal wrote. 
 
Full text of the letter is below. 

March 21, 2013

The Honorable Margaret A. Hamburg
Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland  20933

Dear Commissioner Hamburg:

In an astonishing and alarming incident, a nurse at Yale-New Haven Hospital noticed floating particles in a bag of magnesium sulfate intravenous solution. This product was compounded at Med Prep Consulting, Inc., in New Jersey, prompting a voluntary recall by the company. The contamination was determined to be mold, and a total of five (5) contaminated bags of the product have been found thus far at Yale-New Haven Hospital. Due to the nurse’s vigilance, no patients were harmed by those products. 

This highly troubling incident highlights again the public health threats posed by compounding pharmacies – in this case, Med Prep Consulting Inc. – failing to provide safe pharmaceutical products and FDA failing to protect the public.

As a compounding pharmacy, Med Prep is supposed to provide limited quantities of specialized products, but its products are widely distributed both regionally and nationally. While I am particularly concerned that the contaminated bags were found in a hospital in my home state of Connecticut, I am also deeply troubled by the potential for widespread harm that Med Prep’s contaminated solutions pose on a national scale.

Though I appreciate FDA’s recent decision to inspect compounding pharmacies deemed “high-risk facilities,” I am alarmed that FDA inspections of the Med Prep facility over the past decade resulted in the two Warning Letters that FDA issued to Med Prep in 2001 and 2010 that cited Med Prep’s practices and expressed concern about the sterility of its products.  

In 2001, FDA found that Med Prep was violating FDA regulations by using single-use vials of products more than once and failing to maintain master batch records for products, thereby compromising the sterility of the products. In that Warning Letter, FDA asked for specific response on what the company would do to correct these actions.

In 2010, FDA issued another Warning Letter to Med Prep, informing the company that FDA found that Med Prep was engaging in repackaging behavior that is outside of the scope of the traditional practice of pharmacy. FDA required Med Prep to register as a repackager with FDA or face possible legal action.

Now, in 2013, Med Prep has provided dangerously contaminated products clearly and imminently threatening public health and safety. This lifesaving discovery was made not by FDA inspection, but by watchful health care providers.

According to Sec. 460.200 of the Compliance Policy Guidance for FDA Staff and Industry issued in 2002, FDA states that it will “seriously consider enforcement action” when the scope and nature of a pharmacy’s activities raise the “kinds of concerns normally associated with a drug manufacturer and result in significant violations of the new drug, adulteration, or misbranding provisions of the Federal Food, Drug, and Cosmetic Act.” The Policy specifically lists compounding drugs in anticipation of a prescription and compounding drug products that are commercially available in the marketplace as some of the factors that it will consider when deciding whether to bring an enforcement action. The activities described in the 2010 Warning Letter show that FDA considered Med Prep to be acting outside of the scope of pharmacy practice and engaging in activities that would clearly bring the company into FDA’s jurisdiction.

I ask that you provide the following information as soon as possible but no later than two weeks from today:

1. Were any further inspections done in response to the Warning Letters? If so, please provide results of the inspections.
2. Did Med Prep Consulting Inc. provide magnesium sulfate intravenous solution to Yale-New Haven Hospital based on valid prescriptions?
3. Was there anything unique about the products that Med Prep Consulting Inc. provided to Yale-New Haven Hospital that made them distinct from commercially available products?
4. Were any enforcement actions taken against Med Prep Consulting Inc. after the issuance of the Warning Letters and prior to the recent discovery of contaminated products?
5. What does FDA plan to do to protect the public in the future and ensure that companies like Med Prep Consulting Inc. meet all applicable standards for safety and quality?

This incident marks at least the second time in a year that products from a compounding pharmacy have been discovered to be directly threatening the lives and safety of Americans. This is not an isolated incident. It reflects that the compounding pharmacy industry has been operating without effective oversight and scrutiny as a result of gaps in current laws and FDA regulation. As a result, distributors sell their products without sufficient oversight necessary for safe, widespread distribution of pharmaceuticals.

Thank you for your helpful and timely responses to my previous inquiries into compounding pharmacy practices. I look forward to continuing to work with you on this matter, and I implore FDA to use the full extent of its regulatory and investigatory power to investigate Med Prep and stop dangerous practices both within the company and across the industry. 


Sincerely,


Richard Blumenthal
United States Senate