Imports & sunshine
Pharma companies and FDA have run into similar concerns with state efforts to permit the import of less costly drugs from
other countries. The latest case involves a 2013 Maine law permitting importation of prescription drugs from pharmacies in
Canada and other specific countries. Maine officials assert that the program will help local residents obtain needed medicines,
but Maine pharmacists and manufacturers have filed suit, claiming that the initiative could bring in unsafe products, and
that Maine's action is pre-empted by the FDCA. The case is moving forward following a recent ruling by a Maine judge that
local pharmacists have legal standing to bring such a suit— although drug manufacturers do not (see Kurt Karst's FDA Law Blog,
May 20, 2014 for more details,
And the federal Open Payments program recently went live, largely the result of industry's desire for uniform, national standards
governing the disclosure of pharma company payments to health professionals. Although public access to data on "transfers
of value" by makers of drugs and medical products is likely to hinder industry interactions with medical professionals and
with physicians engaged to conduct clinical research, pharma companies decided that the federal program was preferable to
dealing with multiple state laws.
Under rules issued this past year by the Centers for Medicare and Medicaid Services (CMS), in June companies had to submit
their detailed data on payments to physicians and teaching hospitals for the last five months of 2013. CMS will post the information
as a way to shed "sunlight" on relationships between industry payments and physician prescribing and treatment practices.
The final Sunshine Act provides only partial federal pre-emption of local transparency policies, as states still may require
industry to report additional data and payments to more health professionals. But industry hopes that over time, the CMS program
will establish a disclosure model that satisfies local health authorities.
Uniform drug tracking
Similarly, industry's desire to avoid diverse drug track-and-trace requirements was a prime factor leading to enactment of
the Drug Quality and Security Act (DQSA) of 2013, which lays out a 10-year process for creating a national drug tracing system
through the Drug Supply Chain Security Act (DSCSA) section of DQSA. After years of debating various options for better securing
the drug supply chain to thwart counterfeiters and thieves, supply chain partners lined up behind DSCSA last year to avoid
compliance with a California law establishing its own drug tracking system beginning in 2015.
State laws and biosimilars
The new law pre-empts California and other state tracking programs, reflecting general agreement that a national system is
more capable of identifying genuine medical products and preventing bogus or adulterated drugs from entering the supply chain.
The DSCSA requires manufacturers and distributors to establish systems able to transmit information on prescription drug movement
in the U.S. from production plant to distributors and ultimately to dispensers. With an initial information-exchange phase
set for launch Jan. 1, 2015, FDA is busy consulting with stakeholders on options for data exchange standards able to transmit
information, initially via paper or electronically; a fully interoperable system is required by 2023 that can track drugs
electronically through package-level two-dimensional bar codes.
The drug tracking measure gained traction in Congress last year due to a sense of urgency among policy makers to strengthen
FDA oversight of large drug compounding operations. Although traditional pharmacy compounding is regulated by state law, a
lethal meningitis outbreak linked to contaminated injectibles produced by certain compounders generated a groundswell for
stronger federal controls.
The new policy walks a narrow line between tighter FDA oversight of those compounders that operate more like drug manufacturers,
while retaining state regulation of the many thousands of small entities that provide compounded dosage forms to local hospitals
and doctors. Maintaining a balance between state and federal rules is challenging, though, as seen in emerging disputes between
FDA and compounders over specific policies, such as limits on the production of "office stock" drug supplies by unregulated
compounders—something sought by FDA but opposed by some states. Compounders largely prefer state rules and regulations, and
only a handful of large operators have signed up for the new voluntary FDA regulatory regime.
Jill Wechsler is Pharm Exec's Washington correspondent. She can be reached at firstname.lastname@example.org