By Kimberly Kindy and Lena H. Sun
Commercial drug makers are also pressing a lobbying campaign
aimed at stopping these specialty pharmacies, known as compounders, from making
“knockoff” drugs for people and their pets that the companies say are costing
them millions of dollars in annual profits, records and interviews show.
This rapidly escalating struggle
reaches far beyond congressional efforts to rein in reckless compounding
pharmacies that began in October after tainted steroids from the
Massachusetts-based New England Compounding Center (NECC) were linked to a
meningitis outbreak that has killed 48 people.
Amid a public outcry, lawmakers began considering draft
legislation to address public safety concerns. With a bill in the works, a range
of companies, business associations and health organizations have begun pressing
their own interests along a wide front.
Veterinary groups, for instance, have launched their own
lobbying campaign opposing the drugmakers. These groups warn that any
legislation that required patient-specific prescriptions would deprive them of
vital drug stockpiles and that pets would die at their clinics.
Hospitals want to ensure that any new oversight of compounders
by the Food and Drug Administration does not cripple the firms’ operations,
which could worsen drug shortages.
And the compounders, while agreeing that tighter federal
enforcement of safety standards is needed for the large firms, are vigorously
resisting the drug companies’ bid to limit competition.
The Senate Health, Education, Labor and Pensions Committee is
working on draft legislation directed at compounders and is expected to begin
circulating it to interested groups as soon as next month. The House Energy and
Commerce Committee, meanwhile, is investigating whether lax oversight of NECC by
the FDA contributed to illnesses and deaths.
Since Congress and other federal officials began investigating
NECC this fall, the number of groups lobbying on issues related to compounding
pharmacies has more than doubled, records show.
“Some are making blatant copies of FDA-approved products,” said
Ron Phillips, who is lobbying for the Animal Health Institute, which represents
drugmakers. “You can go to any trade show or to their Web sites and they are openly
promoting this. A clear line needs to be drawn.”
Over the past two decades, many compounders — who custom-mix
medications — have moved from a traditional practice of filling prescriptions
for individual patients to mass producing drugs, often without a prescription.
Sometimes the drugs are similar to those made by drug manufacturers. Today,
compounding is about a $2 billion-a-year industry.
The specialty pharmacists supply about 40 percent of all
intravenous medications used in hospitals, up from 16 percent a decade ago,
according to industry estimates. Veterinary groups estimate that 20 percent of
the medications they prescribe are compounded products.
Compounders also make some of the highest-risk drugs available, sometimes using potent raw
ingredients that must go through a critical sterilization process to ensure
safety. Many of them are injected directly into patients, such as the steroids
linked to the meningitis outbreak, which has sickened 666 people in addition to
those who have died.
Yet compounding pharmacies are not required to follow federal
safety laws — such as testing their medications for contamination and potency
levels — that apply to
commercial drugmakers.
As compounders have moved into bulk
production, federal regulators have sent conflicting signals about when they
will step in.
The drugmaker K-V Pharmaceutical, for instance, won FDA approval in
February 2011 for its drug Makena, which is given to pregnant women to prevent
premature births, and was given the exclusive right to sell it for seven years.
But the following month, the FDA announced it would not take action against
pharmacies compounding a similar product.
The day after that announcement, K-V’s stock dropped by more
than 60 percent. Since then, the company has cut the per-dose price of Makena
from $1,500 to $690.
That episode was widely noted across the drug industry, with
compounding experts calling it a watershed moment.
Earlier this winter, officials from K-V Pharmaceuticals were on
Capitol Hill for two days, lobbying on the issue and telling congressional
staffers that compounded versions of Makena can be “unsafe or ineffective,” said
Sarah Sellers, senior director of epidemiology and risk management for K-V’s
marketing and distributing arm, Ther-RX.
“If an FDA-approved product is medically appropriate, it should
be used preferentially,” Sellers said.
Manufacturers of animal drugs — such as Frontline for flea and
tick prevention and Heartgard for heartworm prevention — have also been pushing
Congress to stop compounders from making what drug companies consider copycat
products.
Compounders say there are times they should be allowed to make
products that are essentially copies — when manufactured products are
unavailable because of drug shortages and when drugmakers have stopped producing
a needed product.
Veterinary compounders and veterinarians are trying to block a
push by drugmakers to require patient-specific prescriptions before a medication
can be made. Matt Wilson, a partner at Animal Clinic Northview in Ohio, said
this creates serious problems in emergency situations. For example, apomorphine
is commonly used to induce vomiting in dogs when they have ingested a poison but
it must be given within hours to save the pet.
“There are so many drugs that are back-ordered and unavailable.
You can’t properly practice medicine if you don’t have these products in hand,”
said Wilson, who uses Wedgewood Pharmacy, which is part of the lobbying
effort.
Instead of measures that could limit mass production or bar
compounds similar to commercial products, compounders are telling Congress they
want more-rigorous safety standards for all compounding pharmacies.
The International Academy of Compounding Pharmacists, the
industry’s largest trade group, is asking for federal and state legislation that
would require compounders to adhere to guidelines that are currently voluntary.
The guidelines run more than 400 pages long and were developed by pharmacists,
doctors and nurses.
“We believe they need to be mandated by law,” said David G.
Miller, IACP’s executive vice president.
Miller said he told congressional
staffers that he still wants state inspectors to retain the authority to enforce
the standards for most compounding pharmacists. Last month,Miller reversed course on his long-held position that all
compounders should be regulated by state boards of pharmacy, saying
manufacturing-style firms that market and sell products without patient-specific
prescriptions should register with the FDA and be inspected by the agency.
The shift in IACP’s position followed a Washington Post
investigation that showed 15 of the nation’s largest compounding pharmacies mass
produce medications, often shipping them across state lines without patient
prescriptions. The Post also reported that shoddy equipment and unsanitary
conditions at some of these firms had caused patient illnesses and deaths long
before this fall’s deadly outbreak but that the firms rarely were penalized.
IACP and other groups are squaring off over which pharmacies
would fall into the new category and face stepped-up FDA enforcement.
Many compounding experts and
drugmakers maintain that size is the key factor for defining this new
category.Express Scripts, a company that has a compounding arm that
makes fertility drugs, is telling Congress that even though it ships to all 50
states, it does not belong in this new group, since it makes medications for
individual patients.
Among those most affected are large hospitals, which often
compound medications in-house. They want to be excluded from increased federal
scrutiny, arguing that they make drugs only for their individual patients.
Many smaller community hospitals do not have the resources to
mix their own medications. If they cannot buy the medications from drug
manufacturers, these hospitals often rely on large compounding pharmacies to
supply pain medication, anesthetics, and drugs commonly used in labor and
delivery. Lobbyists for smaller hospitals say they want more oversight of
compounded products.
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