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 The Senate approved the bill by voice vote, sending it to the White
House, where President Barack Obama is expected to sign it into law.
The legislation also creates a national system for tracking
prescription drugs from manufacturers to retail pharmacies, first
through serial numbers on bottles and later through electronic
codes. The House passed it in September.
More than 750 people were sickened by last year's outbreak of deadly
fungal meningitis and many continue to suffer debilitating pain and
nerve damage. The sickness was eventually traced to a now-closed
pharmacy in Framingham, Mass., the New England Compounding Center,
where inspectors found mold, standing water and other unsterile
conditions. The company shipped more than 17,600 doses of the
implicated steroid injection to 23 states.
Jurisdiction over such large-volume compounders has been murky.
Pharmacies that fill individual prescriptions from a doctor or other
health professional are typically regulated by state boards, but the
Food and Drug Administration regulates manufacturers of medicines.
The compromise bill gives the FDA authority to inspect and close
down large-volume compounders, but it doesn't require the pharmacies
to register with the FDA, as manufacturers of prescription drugs
must do.
The bill attempts to sort out the legal gray area that allowed the
Massachusetts pharmacy and similar businesses to skirt both state
and federal regulations. The measure clarifies the FDA's authority
over high-volume compounding pharmacies that mass-produce
medications, rather than fill doctors' prescriptions.
Under the bill, pharmacies can voluntarily register with the FDA and
submit to federal quality standards and inspections. FDA officials
previously said requiring compounding pharmacies to register with
the agency was crucial to preventing future outbreaks.
The bill's supporters acknowledge that a voluntary approach will
succeed only if doctors and hospitals choose to do business with
FDA-registered pharmacies.
"Nobody will be required to register in this new category," said
Allan Coukell, drug safety expert with the Pew Charitable Trusts,
which lobbied to pass the bill. "The success of the voluntary
category will depend on hospitals, clinics and doctors choosing to
buy from these FDA-registered facilities."
Safety advocates say the bill leaves the door open for more rogue
pharmacies like the one that caused last year's outbreak.
"This voluntary approach will continue to expose patients to
potentially unsafe, mass-produced compounded drugs that are not
approved or evaluated by the FDA," Rep. Rosa DeLauro, D-Conn., said
after the House passed the bill.
FDA officials told Congress last year that regulating businesses
like the NECC has been a struggle because of a "patchwork" of
conflicting court decisions over the federal agency's authority to
deal with pharmacies.
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Traditional compounding pharmacies, generally small operations that
fill individual doctors' prescriptions, will continue to be
regulated by state pharmacy boards. Pharmacies that expand into
shipping drugs without doctors' prescriptions can voluntarily
register with the FDA as "outsourcing facilities," subject to
quality standards and reporting requirements similar to
manufacturers.
The FDA will retain the power to shut down any outsourcing pharmacy,
registered or not, that does not meet quality standards or engages
in illegal compounding, such as mass-producing copies of
manufactured drugs.
Experts who helped craft the bill predict that nearly all large
compounding pharmacies will register with the FDA as a cost of doing
business.
But critics question how the FDA will be able to identify businesses
that aren't following regulations.
Even the compounding industry's chief lobbying group said the bill
will not stop pharmacies like the one that caused last year's
outbreak, and said it could lead to more confusion over pharmacy
regulations.
"If the goal of this legislation is to prevent another NECC, which
has been stated many times over, then the American public must know
that this bill will not accomplish that goal. A voluntary category
of outsourcing facilities is not the answer," the International
Academy of Compounding Pharmacists said in a statement.
The voluntary approach to regulation was a compromise forged by
Republicans and Democrats in the GOP-controlled House. Earlier
versions of the bill drafted in the Democratic-controlled Senate
would have made registration mandatory.
Despite criticisms of the approach, the bill has garnered broad
support, in part because it was bundled together with separate
legislation designed to track prescription drugs throughout the U.S.
supply chain.
The so-called track and trace system, long sought by doctors and
patient groups, is designed to help authorities catch counterfeit or
stolen drugs that increasingly have been making their way into the
U.S. from overseas.
Drugmakers will be required to add serial numbers to all drug
packages within four years. After 10 years the industry must upgrade
to electronic codes that can be used to track medicines from the
factory to the pharmacy. Drug distributors, packagers and
wholesalers will be required to verify the distribution history of
the products they ship.
[Associated
Press MATTHEW PERRONE, AP Health Writer]
Follow Matthew Perrone
on Twitter:
http://twitter.com/AP_FDAwriter.
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