The Drug Quality and Security Act would allow businesses combining elements of two or more drugs to “voluntarily register with FDA and operate under FDA regulation,” explained U.S. Rep. Fred Upton, R-St. Joseph, chairman of the House Energy and Commerce Committee, which oversees the FDA.
The bill, approved in the House last month, would allow large-scale compounders to register to be overseen by the FDA in hopes of preventing another disaster like the nationwide fungal meningitis outbreak linked to New England Compounding Center in Massachusetts.
The outbreak, linked to tainted steroids from the facility, has resulted in 264 cases of related illness in Michigan, including 19 related deaths. Eight of those deaths have been in Livingston County.
The NECC disaster demands mandatory FDA oversight of compounding pharmacies, said Kathy Pugh, whose mother, Evelyn Bates-March, a Hamburg Township resident, is recovering from an injection of tainted steroids from the facility.
“It’s not something that can be volunteered. The same thing’s going to happen,” Pugh said.
“All they’re doing is slapping an itty-bitty Band-Aid and people are still bleeding out. It’s not going to work. It’s not going to solve the problem,” she added.
An 'important step'Supporters of the bill claim larger compounding pharmacies, which combine elements of multiple drugs, will seek the FDA regulation so they can market their products as FDA-regulated.
The bill maintains existing law exempting FDA approval of compounded drugs, however. Most oversight of compounding pharmacies is left to state boards of pharmacy.
The bill would prevent more deaths stemming from compounding pharmacy mistakes, Upton said.
“The sad truth is that, yes, they could have been prevented. This legislation is an important step in helping to prevent any such tragedy from ever occurring again,” he said before the House approved the bill.
“We are near the resolution of last year’s deadly outbreak. So let’s say to those families and to those who lost loves ones and those who still are suffering today, ‘With this bill we are going to say never again,’” Upton added.
U.S. Rep. Mike Rogers, R-Howell, also sits on the Energy and Commerce Committee.
When asked how voluntary FDA oversight could increase compounding pharmacy safety, Rogers’ office would only say he supports the House-approved bill.
“Congressman Rogers supported a bipartisan, bicameral effort to add additional FDA oversight of compounding pharmacies. By improving two-way communication between FDA and state regulators, we prevent a public health emergency like NECC from happening again,” Kelsey Knight, Rogers’ spokeswoman, said.
Dody Viola, who was injected with tainted NECC steroids, wasn’t nearly as enthusiastic about the bill.
Viola, a social worker with an office in Brighton, said additional oversight of compounding pharmacies is a crucial part of preventing another NECC-like tragedy.
She said voluntary participation would not result in greater consumer protection.
“If it were you, would you voluntarily agree to be overseen and would you pay a fee for having that done? I don’t think so,” she said.
“I don’t think that makes any sense. It’s something they’re tossing out to hopefully appease the people that really care,” she added.
The bill also answers confusion about whether compounding pharmacies can market and advertise their products, a major issue industrywide, according to the Energy and Commerce Committee office.
House Resolution 3204, according to a committee analysis, also would require the FDA to coordinate safety of compounded drugs with states and protect smaller-scale, “traditional pharmacy compounding” in local pharmacies.
Voluntary system questionedAnother section of the bill known as the Drug Supply Chain Security Act would create a nationwide prescription-drug tracking program, and a nationwide standard to prevent pharmaceutical counterfeiting, according to the House committee.
The proposal appears to have split support in the pharmaceutical industry.
The International Academy of Compounding Pharmacists, an advocacy organization for compounding pharmacists, maintains the bill in its current form would not result in greater FDA oversight of compounding facilities.
The academy said the bill’s vague definitions of terms alone would lead to multiple court challenges about who must follow the rules.
Compounding pharmacies will not voluntarily choose to be regulated more and pay a fee to cover the costs, said David Ball, the academy’s spokesman.
Ball said FDA oversight in the bill should be mandatory.
“We don’t think that a voluntary system protects the public, ever,” he said.
“We just don’t see a clear path to regulating and overseeing and managing these larger operations that are currently pharmacies but may appear to be more like manufacturers,” Ball added.
The bill is supported by the National Community Pharmacists Association, however.
In a statement, the association said the bill will streamline federal rules for larger compounding pharmacies.
“This compromise proposal provides a balanced and effective approach to address critical and complex issues surrounding compounded medications, as well as strengthening our nation’s pharmaceutical supply chain,” the association said in a statement.
“NCPA commends the Congress for crafting bipartisan legislation that addresses the New England Compounding Center tragedy, ensures quality standards for all compounded pharmaceuticals and maintains patient access to vital compounded medications,” the statement adds.
The Maryland-based American Society of Health-System Pharmacists, echoed support for the legislation.
Kasey K. Thompson, the organization’s vice president of policy, said the bill would create better communication between the federal government and states on compounding pharmacy activity.
“ASHP believes this legislation will help the FDA focus their regulatory efforts on entities that are compounding outside the scope of traditional pharmacy compounding, while leaving traditional pharmacy compounding under the oversight of state boards of pharmacy,” Thompson said in a statement.
The state Department of Licensing and Regulatory Affairs, which licenses and regulates through LARA with the Michigan Board of Pharmacy, wouldn’t comment on whether the bill would improve the safety of compounded drugs in Michigan.
There are 244 Michigan-based and licensed compounding pharmacies, and another 214 compounding pharmacies outside Michigan licensed by the state to ship their products here.