The International Academy of Compounding Pharmacists has spent more than $1 million lobbying Congress in the last 10 years and has successfully defeated laws and regulations opposed by the compounding industry, the AP reported.
On Wednesday, the owner of the New England Compounding Center refused to testify before a House of Representatives committee that's also investigating the steroid/meningitis outbreak.
After a series of questions from members of the House Energy and Commerce Committee, Barry Cadden, co-founder of the New England Compounding Center, said: "Under advice of counsel, I respectfully decline to answer under basis of my constitutional rights and privileges, including the Fifth Amendment," the AP reported.
But FDA Commissioner Margaret Hamburg told the House committee Wednesday that new laws are needed to give her agency more legal authority and funding to oversee compounding pharmacies.
"The challenge we have today is that there is a patchwork of legal authorities that oversee the action we can take," Hamburg, who was nominated to head the FDA by President Obama in 2009, said in prepared testimony, the AP reported.
She said Congress should draft new laws and provide more funding to police large specialty pharmacies, such as the New England Compounding Center, which aren't subject to the same FDA scrutiny as big drug manufacturers.
"In light of growing evidence of threats to the public health, the administration urges Congress to strengthen standards for non-traditional compounding," Hamburg said.
Republican lawmakers, who constitute the majority party in the House of Representatives, spent considerable time focusing on the New England Compounding Center's checkered past, asking Hamburg why regulators at the FDA and the Massachusetts board of pharmacy did not take action against the company
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