October
30, 2019
More drugs are in short supply for
longer periods of time due to a fundamentally flawed pharmaceutical supply
chain, according to a new report.
The number of ongoing drug
shortages has increased from 2017 to 2018 after declining from a
peak in 2011. Shortages have also been lasting longer, in some cases more than
eight years, according to a new report from the Food and
Drug Administration's Drug Shortages Task Force. Two-thirds of the 163 products
studied had a generic version, had been on the market for decades and were
relatively cheap off-patent drugs.
Sixty-two percent of the
pharmaceuticals analyzed went into shortage after supply disruptions related to
manufacturing or quality problems.
"We feel there is market
failure here," Dr. Janet Woodcock, director of the FDA's Center for Drug
Evaluation and Research, said during a House Energy and Commerce Committee
hearing Wednesday on the pharmaceutical supply chain. "It is an economic
problem where cost minimization and driving to the lowest price then
disincentivizes investment by manufacturers, which then gets them out of the
market or eventually gets them into manufacturing difficulties."
The root causes stem from a lack of
incentives to produce less profitable drugs and a "race to the
bottom" pricing mentality, a lack of recognition and financial incentive
to reward quality manufacturers, and logistical and regulatory hurdles to
increase production during a shortage, the FDA said.
The impact is significant.
According to an analysis published in JAMA of the
norepinephrine shortage in 2011 and 2012, deaths increased by 3.7 percentage
points and there were estimated losses of $13.7 billion nationwide.
One of the latest examples is the
shortage of vincristine, which is used to treat leukemia, as well as other
types of cancer. Pfizer, which has had about 98% of the market and became the
sole-supplier in July when Teva Pharmaceuticals made a "business decision"
to stop supplying the drug, experienced a manufacturing delay in early October.
The Children's Oncology Group wrote
in a letter to the cancer
community that it is "greatly concerned that some children are already
being impacted by this shortage and by the understandable anxiety this creates
for all families of children with cancer." Care is often delayed when
shortages arise, studies have shown.
Pfizer offered a limited one-time release on Oct.
25 and will require providers to send in specific patient and dosing
information to get subsequent doses. Since vincristine is a "work
horse" chemotherapy medication, it may represent hundreds of patients
within Cleveland Clinic alone who require multiple doses, said Chris Snyder, a
Cleveland Clinic pharmacist and drug shortage specialist.
The lifesaving drug only costs
about $8 for a sterile vial, Woodcock said.
"If we are only willing to pay
that much, manufacturers are going to drop out of the market," she said
during the hearing.
The FDA proposed three main
solutions, one of which was to create a rating system that would evaluate the
robustness of a manufacturing facility's quality system and reward
high-performers, which drew the most support from pharmaceutical experts.
"There should be a very public
scorecard for manufacturers," said Scott Knoer, chief pharmacy officer at
Cleveland Clinic, adding that there is a very low bar for offshore companies
who produce medication. "Because price has been the No. 1 issue that
people, PBMs and insurance companies drive to, low quality has been allowed to
become acceptable. Technically not acceptable, but not enough infrastructure
and desire to ensure quality and safety."
It would make a big difference to
be able to purchase drugs based on quality, and hopefully decrease shortages
and recalls, said Erin Fox, a drug shortage expert who is the senior director
of drug information and support services at University of Utah Health.
Drug purchasers have limited access
to any quality data other than if the FDA approved it, which doesn't ensure
reliability, Woodcock said.
"If we could rate quality
maturity, which ensures reliability, we could assign some type of system that
would hopefully incentivize some rewarding for value in the healthcare system
purchasing chain," said Woodcock, adding that the FDA is seeking real-time
data from manufacturers, although that would require congressional action.
Another solution was to collect and
analyze comprehensive information to characterize shortages, quantify their
effects and closely observe the contracting practices that may be driving them.
Healthcare organizations should
also pay more for generic drugs—and for high-performing manufacturers in
particular—ensuring that they continue to supply critical, older generic drugs,
the agency said.
"I think we do need to pay
more to a create a more sustainable market, but there have to be incentives for
hospitals to do so," said Fox, explaining that the current payment
structure does not encourage hospitals to purchase based on quality.
In 2018, 88% of the manufacturing
sites making active pharmaceutical ingredients and 63% of sites making finished
dosage forms were located overseas, according to the report. This represents a
national security issue that further fragments the supply chain, experts said.
"There is capacity to produce
API in the U.S. but there is not economic incentive," said Woodcock,
citing lower labor costs less environmental regulation overseas.
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