As reported on Digital Journal
a rare fungal form of meningitis has now spread to 23 U.S. states. As of Monday, 105 people are reported to have contracted the disease which has been traced back to contaminated steroid shots manufactured by a Massachusetts-based compounding pharmacy.
CNN medical correspondent, Dr. Sanjay Gupta, appeared on Anderson Cooper 360
and explained how compound pharmacies work. He stated that pharmaceutical manufacturers produce the actual medications and those medications are then sent in bulk to a compounding pharmacy. The compounding pharmacy divides the medication into smaller doses, sometimes concentrating the doses, sometimes mixing it with other medications. They do not actually manufacture the medication, but instead they are changing the dosage of the medication and mixing it in some way.
Call for Less Government Regulations
On Tuesday, Fox News host Neil Cavuto spoke with Napilitano about the outbreak that has claimed the lives of 8 people. Napilitano claimed that the tainted injection is a result of government regulation, saying
"It is well known that the state of Massachusetts is the most highly-regulated state in the union, with the government that is most in your face. It has a government that is physically present at the plants of the people and entities that they regulate…I don’t know if they have a person physically present in this facility, but they have the right to do so. So it is obvious that the state cannot keep its people — and others, when [the shots were] shipped outside the state — safe."
When asked what the alternative was to government regulations Napilitano relied:
"The alternative is to have insurance companies do the regulating because they would be on the hook. Hear me out. When someone is injured because the state drops the ball, the state can’t be sued. When someone is injured because an insurance company drops the ball, the insurance company can be sued. So you darn well believe that they are going to be certain that every batch of chemicals that is mixed in that facility is safe because if it is not, they are going to pay for it."
reports that Napilitano warned that this type of outbreak will happen again, saying:
“The government is incapable of doing what it has charged itself with the responsibility of doing because it has no competition and there are no consequences when it fails.”
Call for More Government Regulations
The FDA currently does not have the authority to regulate compound pharmacies however, and thus have not had the opportunity to fail or succeed. Under current FDA law
"pharmacies which maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy and medicine and which are regularly engaged in dispensing prescription drugs or devices, upon prescriptions of practitioners licensed to administer such drugs or devices to patients under the care of such practitioners in the course of their professional practice, and which do not manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs or devices at retail."
In 2003 members of the FDA appeared before the Senate Committee on Health, Education, Labor, and Pensions. During that meeting they testified
"FDA recognizes that states have the direct ability to regulate pharmacy compounding and direct access to prescription records. However, limited state resources and varying standards and regulatory requirements are factors that affect the adequacy of state regulation. when pharmacy compounding more closely approximates commercial manufacturing, FDA has an interest in regulating that practice as it does all other drug manufacturing.
FDA believes it is in the best position to address the quality of bulk drug substances used in compounding. Many of these drugs are imported from abroad and individual states are unlikely to have the ability to conduct inspections of foreign producers and ensure the quality of these active ingredients in compounded products. FDA believes it is appropriate for the Agency to continue to investigate allegations of poor quality compounded drugs, in conjunction with the states, whenever possible. However, we also must act without states when state involvement is not forthcoming because of resource constraints or for other reasons."
Some in the medical community appear to disagree with Napilitano as well. Dr. William Schaffner, chairman of Preventive Medicine at Vanderbilt University Medical Center, told CBS This Morning
he wants to see more government regulation of compounding pharmacies, saying:
"They [compound pharmacies] are not regulated the way the major pharmaceutical companies are. They seem to have fallen into a regulatory gap. That's something that really needs to be addressed by the Congress."
Lawmakers are also calling for more federal regulations of compound pharmacies. According to WFAA
and Fort Mill Times
reports, lawmakers are now calling for the FDA to regulate all compound pharmacies.