MESSAGE
| DATE | 2016-10-12 |
| FROM | Ruben Safir
|
| SUBJECT | Subject: [Hangout-NYLXS] Fwd: Mylan to Settle EpiPen Overpricing Case for
|
Just FWIW and FYI
-------- Forwarded Message --------
Subject: Mylan to Settle EpiPen Overpricing Case for $465 Million |
Pharmacist eView | October 12, 2016
Date: Wed, 12 Oct 2016 14:03:59 -0700
From: Pharmacist eLink
To: ruben-at-mrbrklyn.com
( )
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**»** **Industry News**
Mylan to Settle EpiPen Overpricing Case for $465 Million
( #888949 )
Theranos Will Close Labs and Walgreens Testing Sites
( #888153 )
Uninsured? San Jose Pharmacy Will Give You Needed Drugs for Free
( #888410 )
UnitedHealth Accused of Gouging Customers on Prescription Drugs
( #888411 )
**»** **Drugs and Treatment**
Antibiotic History of a Hospital Bed May Increase a Patient's Risk of
CDI ( #888952 )
Carfentanil Linked to 19 Deaths in Michigan's Wayne County ( #888409 )
Insulin Prices Soar While Drugmakers' Share Stays Flat ( #888947 )
**»** **Healthcare Legislation & Regulation and Medicaid/Medicare**
FDA Panels Urge Stronger Minimum Dosages of Naloxone ( #888154 )
Quicker Generic Approvals, Less Litigation Among Goals of FDA Rule (
#888414 )
Supreme Court Denies Review in Hatch-Waxman Case ( #888412 )
Washington Governor Issues Order on Fight Against Opioid Abuse ( #888948 )
**Industry News**
( )
**Mylan to Settle EpiPen Overpricing Case for $465 Million**
_New York Times (10/08/16) Thomas, Katie
_
Mylan on October 7 reported that it had reached a $465 million
settlement with the Justice Department and other government agencies
over questions on whether the company had overcharged Medicaid for its
EpiPen auto-injector by improperly classifying it as a generic drug. The
federal government said that Mylan had been told multiple times that it
was wrongly classifying the EpiPen, which led the Medicaid and Medicare
programs to overpay for the product. In a statement, Mylan said the
settlement did not imply any admission of wrongdoing. It also said the
settlement had not been finalized, and that it expected to enter into a
corporate integrity agreement with the Office of the Inspector General
for HHS. "This agreement is another important step in Mylan's efforts to
move forward and bring resolution" to the EpiPen issue, CEO Heather
Bresch said in the statement. The makers of generic drugs pay rebates to
the government of 13 percent of the average manufacturers' price. But
manufacturers of brand-name drugs must offer discounts of about 23
percent off that average price, or the difference between the average
price and the best price they have negotiated with any other American
payer, whichever gives the bigger discount.
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( )
**Theranos Will Close Labs and Walgreens Testing Sites**
_Wall Street Journal (10/06/16) Carreyrou, John; Weaver, Christopher
_
Theranos reports it will close its clinical labs and Walgreen's testing
centers, shrinking its workforce by more than 40 percent. The moves mark
a dramatic retreat by the company and founder Elizabeth Holmes from
their core strategy of offering a long menu of low-price blood tests
directly to consumers. Those ambitions already were endangered by
crippling regulatory sanctions that followed revelations of shortcomings
in Theranos's technology and operations. In a statement posted on the
company's website late Wednesday, Holmes said: "We will return our
undivided attention to our miniLab platform. Our ultimate goal is to
commercialize miniaturized, automated laboratories capable of
small-volume sample testing, with an emphasis on vulnerable patient
populations, including oncology, pediatrics, and intensive care."
Theranos launched a partnership with Walgreens drugstores to collect
blood samples at the community pharmacy chain and send them to Theranos
labs for analysis. In October 2015, the Wall Street Journal detailed
concerns about the company's testing accuracy. Theranos later voided all
results from its proprietary device for 2014 and 2015, though the
company said it was not aware of any patient harm resulting from its
tests. In June, Walgreens Boots Alliance closed all of the
blood-collection locations opened in the Theranos partnership.
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**Uninsured? San Jose Pharmacy Will Give You Needed Drugs for Free**
_San Francisco Chronicle (10/05/16) Colliver, Victoria
_
Better Health Pharmacy, located in San Jose, CA, distributes donated
medicines, at no cost to the patients who need them. The pharmacy is the
only one in the state that exclusively distributes donated medicines.
"As long as you have a valid prescription and I have medication in
stock, we will fill it for you," said Khanh Pham, lead pharmacist for
the nonprofit pharmacy, which accepts donated medications from nursing
homes, pharmaceutical manufacturers, and wholesalers. With the rising
cost of prescription drugs, many patients are struggling to afford their
medications, yet more than $100 million in unused, unexpired medications
get destroyed in California annually. Since the pharmacy opened a year
ago, it has filled more than 6,000 prescriptions, projected to be worth
at least $200,000, for more than 1,200 patients, pharmacy officials
said. Accepting donated medication became legal in California in 2005,
though the law does not allow for reuse of controlled substances such as
opioid analgesics. Twenty states have active repository programs,
according to the National Conference of State Legislatures, and another
18 states have enacted legislation but are not operating their programs.
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**UnitedHealth Accused of Gouging Customers on Prescription Drugs**
_Bloomberg (10/05/16) Feeley, Jef
_
In a new lawsuit, a group of UnitedHealth customers allege the health
insurer overcharged them for prescription drugs. The lawsuit claims the
customers made copayments for the drugs that were much higher than the
costs of the actual drugs. The complaint asserts the overcharges were
"improper and illegal" because UnitedHealth was already paid to offer
prescription drugs through health-insurance premiums. In addition, the
suit charges the insurer of clawing back the excess payments from
pharmacies to boost its bottom line. The lawsuit, Mohr v. UnitedHealth
Group Inc., is seeking class-action status on behalf of tens of
thousands of customers.
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**Drugs and Treatment**
( )
**Antibiotic History of a Hospital Bed May Increase a Patient's Risk of
CDI**
_JAMA Internal Medicine (10/10/16) Freedberg, Daniel E.; Salmasian,
Hojjat; Cohen, Bevin
_
Researchers investigated whether there is a link between receipt of
antibiotics by prior hospital bed occupants and an increased risk for
Clostridium difficile infection (CDI) in subsequent patients who occupy
the same bed. The team, led by Daniel E. Freedberg, MD, of Columbia
University Medical Center, New York, conducted a retrospective cohort
study of adults hospitalized in one of four facilities between 2010 and
2015. The primary outcome was incident CDI in the subsequent patient to
occupy the same bed. Among more than 100,600 pairs of patients who
sequentially occupied a particular hospital bed, there were 576 pairs
(0.57 percent) in which subsequent patients developed CDI. There was a
significant association between receipt of antibiotics in prior patients
and incident CDI in subsequent patients, even after adjusting for
various factors known to increase CDI risk. The researchers identified
no other factors related to the previous bed occupants besides
antibiotics that were associated with a higher risk for CDI in
subsequent patients. The authors note that although the increased risk
was small, it "is of potential importance given the frequency of use of
antibiotics in the hospital. These data imply that patient-to-patient
transmission of C. difficile or other bacteria that mediate
susceptibility to CDI takes place in the nonoutbreak setting and in the
face of a multifaceted effort seeking to prevent health care–associated
CDI."
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( )
**Carfentanil Linked to 19 Deaths in Michigan's Wayne County**
_Detroit Free Press (10/06/16) Hall, Christina
_
Michigan health officials report that carfentanil has been linked to at
least 19 deaths in Wayne County since July. The animal tranquilizer is
being mixed with heroin and other street drugs, they say. "The Wayne
County Medical Examiner reported 19 deaths associated with carfentanil,
and in all cases where it was present, it was combined with other
opioids including heroin, U47700, or other designer opioids," according
to a news release Thursday. The Michigan Department of Health and Human
Services noted there has been an increase in severe opioid-related
toxicity in southeastern and central Michigan reported to the Michigan
Regional Poison Control Center at Children's Hospital of Michigan in the
past week. Health officials noted that many of the patients "fit the
clinical picture expected with carfentanil but because there is no
currently validated testing, these cannot be confirmed." The news
release added that carfentanil has also been associated with numerous
overdose deaths in nearby Ohio.
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( )
**
Herbal and Dietary Supplements Tied to Liver Damage**
_Reuters (10/06/16) Rapaport, Lisa
_
As many as 50 percent of American adults take herbal and dietary
supplements, but researchers say use of these products is leading to
more and more cases of chemical-induced liver damage. According to a
research review, the share of diagnoses traced to herbal and dietary
supplements has climbed to 1 in 5 today from fewer than 1 in 10 a decade
ago. While supplements are generally harmless to the liver, they can
create risk when overused, taken concomitantly with other supplements or
conventional medications, or consumed over an extended period of time.
Problems can be difficult to detect, however, because damage to the
liver can take months or even years to present and also because
physicians often are not on the lookout for adverse events because
patients have not informed them about supplement use. The researchers,
who examined several years of published studies plus 130 cases tied to
supplements and reported in a national registry of drug-induced liver
injuries, report their findings in Hepatology.
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**
Insulin Prices Soar While Drugmakers' Share Stays Flat**
_Wall Street Journal (10/08/16) Roland, Denise; Loftus, Peter
_
Although insulin prices are rising steeply, most of the revenue from the
increases is not going to the drug manufacturers. It is largely the PBMs
that benefit. Eli Lilly, Novo Nordisk, and Sanofi are the major
manufacturers of insulin, and they are collecting about the same or less
than they did several years ago. The price increases reflect the growing
role of PBMs that negotiate rebates and fees based on list prices.
"Prices for these products have increased," says Aaron Kesselheim, an
associate professor at Harvard Medical School who has researched insulin
costs. "It's also the case that there are more patients under
high-deductible health plans and who may have a greater copay and
coinsurance, and they’re being exposed to a larger share of the prices
as well." Net prices have stayed the same or fallen in the past 2 years
as the pharmaceutical companies compete to offer ever-deeper discounts
to stay on the preferred drug lists at insurers and the PBM middlemen.
The reason drugmakers sharply raise list prices without a corresponding
increase in net price is that PBMs demand higher rebates in exchange for
including the drug on their preferred-drug lists, says Enrique Conterno,
president of Lilly's diabetes business.
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**Healthcare Legislation & Regulation and Medicaid/Medicare**
( )
**FDA Panels Urge Stronger Minimum Dosages of Naloxone
**
_Miami Herald (10/06/16) Pugh, Tony
_
Two federal advisory committees on Wednesday recommended that the Food
and Drug Administration (FDA) authorize stronger minimum dosages of
naloxone, the lifesaving drug that reverses the effects of an opioid
overdose. The FDA's Anesthetic and Analgesic Drug Products Advisory
Committee and Drug Safety and Risk Management Advisory Committee voted
15-13 to recommend increasing the minimum amount for an injectable and
I.V. dose of naloxone—currently 0.4 mg—when considering approval of new
naloxone products for use outside of a hospital or medical setting. The
panels also voted against recommending the FDA approve different minimum
dosing standards for children and adults, which are currently the same.
The recommendation of the panels will be further explored by the FDA's
Center for Drug Evaluation and Research. No timetable for future action
has been set. The committees' decision comes as authorities wrestle with
an epidemic of overdose deaths from heroin laced with fentanyl and
carfentanil, both powerful synthetic opioids.
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**Quicker Generic Approvals, Less Litigation Among Goals of FDA Rule
**
_Bloomberg BNA (10/06/16) Mixter, Bronwyn
_
The Food and Drug Administration (FDA) has issued a new final rule on
generic drug applications aiming to speed approvals and cut unnecessary
litigation, as well as bring "business certainty" to both generic and
branded drugmakers. The rule implements portions of a 2003 Medicare drug
law and governs approval of abbreviated new drug applications (ANDAs)
and 505(b)(2) applications. The 2003 Medicare law, the Medicare
Prescription Drug, Improvement, and Modernization Act (MMA), addressed
key concerns identified in a Federal Trade Commission report on
anticompetitive strategies that could delay access to generic drugs. The
FDA says the clarification in the final rule is intended to help the
agency implement statutory provisions that permit 505(b)(2) and ANDA
applicants to omit protected conditions of use from their labeling and
obtain approval for conditions of use that aren't covered by unexpired
patents or exclusivity. The rule also addresses scenarios in which a
30-month stay may be terminated. Under the Hatch-Waxman Act, a Paragraph
IV certification triggers a statutory 30-month stay of approval of the
ANDA/generic drug. Also, the FDA said in the final rule that the first
generic drug applicant is required to notify the FDA within 30 days of
the date of first commercial marketing of the drug product.
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**Supreme Court Denies Review in Hatch-Waxman Case
**
_Bloomberg BNA (10/04/16) Elfin, Dana
_
The U.S. Supreme Court on October 3 denied review of a petition filed by
Amphastar Pharmaceuticals that asked whether the Federal Circuit
properly interpreted the scope of the safe harbor in a case involving a
process patent for testing the anticoagulant drug enoxaparin sodium
(Lovenox—Sanofi Aventis). Analysts say the rejection of the petition
means that a gray area of the law governing generic pharmaceuticals will
remain unclear, and it also means potential obstacles for makers of
biosimilars. "The potential impact for makers of biosimilars is that
branded companies could use similar process patents [to the one in the
Lovenox case] as a way of stifling biosimilar development," says patent
attorney Shashank Upadhye. The Hatch-Waxman Act's safe harbor can exempt
from infringement liability any activity that's "reasonably related to
the development and submission of information" to the Food and Drug
Administration (FDA). The harbor is typically used by generic companies
that perform certain activities prior to the market launch of their
products. In the ruling that the Amphastar petitioners asked the High
Court to review, the U.S. Court of Appeals for the Federal Circuit held
that the safe harbor did not apply to information that may be "routinely
reported" to FDA after marketing approval. This meant that the safe
harbor's protection from infringement liability did not extend to
Amphastar's ongoing bioequivalence testing for its generic version of
the anticoagulant drug.
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**Washington Governor Issues Order on Fight Against Opioid Abuse
**
_Peninsula Daily News (WA) (10/10/16)
_
Gov. Jay Inslee of Washington ordered on Friday state agencies to work
with local public health, tribal, and other officials to prevent
unnecessary prescribing of opioid analgesics and expand treatment for
those addicted to the drugs. Inslee's executive order calls for efforts
to prevent overdose deaths, such as increasing access to naloxone. "We
all have an important role to play in the statewide movement to fight
one of the most devastating crises facing our communities today: the
public health crisis of opioids and heroin," the governor said in a
statement. State agencies must report on their progress in the battle
against opioid abuse by the end of the year. Washington state recorded
more than 700 opioid overdose deaths in 2015.
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**October 12, 2016**
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