RyMat Inc.: A Look At Generic vs. Brand Pharmaceuticals

Generic vs. Brand‐Name Drugs:
How much are you really saving?
Is it worth the risk?
Risk?
Generic vs. Brand‐Name Drugs:
How much are you really saving?
Is it worth the risk?
Risk?

What happens when a
brand name goes generic?

What happens when a brand name goes generic?
• At the end of an approximately seven-year period of exclusivity, the FDA allows one
specific generic to be the first to market.
• That generic is given a period of time of exclusivity for about six months.
• At the end of that time period, any manufacturer that can prove that it can achieve the
same drug concentrations in the blood that the brand name does can make a generic.
• Manufacturers of generics aren’t required to do studies in people to prove safety. It is
assumed that if they can achieve same blood concentration, they will achieve same
results.

Do generics have to have the
same formula, effect, side effects?

Do generics have to have the same formula,
effect, side effects?
• The generics have to have the same number of milligrams of drug that is included on
the label in the pills.
• In addition, the drug needs to get you within 10 percent above or below the blood
concentrations achieved with the brand for the FDA to approve the generic, and in
reality, they only usually vary by 3-4 percent in one direction or another.
• It is possible that one generic will get you a 3 percent lower concentration than the
brand and another can get you a concentration that is 3 percent above the brand and
therefore the two generics can be 6% different from each other.
• Most people will never notice a difference.

Do generics have to have the same formula,
effect, side effects?
• According to the FDA, generic drugs do not need to contain the same inactive
ingredients as the brand name product.
• Inactive ingredients are those that have nothing to do with the therapeutic
action of the drug; binding materials, dyes, preservatives, and flavoring
agents.
• That’s why sometimes a drug you have been taking will suddenly look
different.
• It usually means a different manufacturer has made that pill than the one you
had before.
• Also, given individual variations, a person can have an allergic reaction to an
inactive ingredient in one generic and not another.

But are all generics really created equal?

• Not exactly.
• The FDA actually assigns letter grades when approving generics:
 An “A” means the drug is exactly the same as the once- patented drug it's
mimicking, while a
 “B” might vary slightly in how it’s absorbed by the body.
• This information usually isn’t part of the drug’s literature; patients would have
to ask the pharmacist for it.
• The agency also allows the generics' concentration of active ingredient in the
bloodstream to be as much as 20 percent below or 25 percent above the
brand's—a fairly wide window of variability.

• The FDA’s policies also mean a drug’s bioequivalence doesn’t actually have
to be exactly equivalent:
• When drug companies lose exclusivity to manufacturing, they release the
drug’s recipe, but not how to make it.
• That’s left for the generic suppliers to figure out. And they don't always get it
right.

• Eight out of 10 prescriptions written in the United States are
filled with the no-brand name, generic version of the drug
prescribed by a doctor, and every year generic drugs save
American consumers more than $200 billion in prescription
costs.
• Global generic spending is set to double by 2016 reaching 400-
$500 billion.

Beware the Risks of Generic Drugs
Copies aren't always as good as the original

• In 2002 the FDA acknowledged it did not have the
resources to adequately monitor foreign manufacturing.
• This became especially alarming when FDA Commissioner
Margaret Hamburg, MD, acknowledged that 80% of active
pharmaceutical ingredients (APIs) come from foreign
sources.

Bloomberg Expose:
This study revealed that a number of major generic drug
manufacturers in India systematically fudged data.
Bloomberg News (Dec. 3, 2014)

Bloomberg Expose:
Sun Pharmaceutical Industries, Ltd.
• According to Bloomberg, the company deleted bad test results.
• Chemical analysis (chromatography) of drug samples is essential to establish purity.
• If the test results are not up to standards, the entire batch of medication is supposed to be
thrown out.
• But Bloomberg reported that a quality-control worker at Sun Pharmaceutical merely hit the
delete button on the computer to get rid of the unwelcome results.
• As a result, a batch of medications was shipped to the U.S. that probably did not pass quality
control measurements.

Bloomberg Expose:
In 2013, Sun acquired Ranbaxy Laboratories

Bloomberg Expose:
• Ranbaxy admitted it falsified data and paid $500 million in fines “to
resolve claims that it sold subpar drugs and made false statements
to the Food and Drug Administration about its manufacturing
practices at two factories in India”
• Ultimately, Ranbaxy was barred from exporting drugs to the United
States from its Indian manufacturing plants.
New York Times, May 13, 2013

Other Problems in India
Bloomberg Expose:
“A review of FDA documents by
Bloomberg News found that similar
actions on quality tests have happened
at dozens of other companies’ plants
across India that make drug
ingredients and pills for export to
the U.S.”

• There are 600 FDA-registered drug companies in India.
• They are spread out all over the vast country, but there are only 12 FDA
inspectors.
• Not surprisingly, they have only visited a fraction of the factories.
• They usually have to announce well in advance that they are coming, which to
our way of thinking defeats the purpose of such inspections.
• In the U.S., all FDA inspections are unannounced so that the company cannot try
to clean up its act in advance.

• Over the last five years the FDA has banned
products from 44 different Indian drug-making
facilities.
• That should give insurance companies some
cause for alarm when they insist that their
customers must use generic rather than
brand name drugs.

• The FDA reprimanded the Indian drug manufacturer Wockhardt for hiding unwelcome test results
and deleting data.
• This is not the first time Wockhardt has run into trouble.
• Since April of last year the company has recalled hundreds of millions of tablets and capsules.
• They included popular blood pressure medicines such as amlodipine and lisinopril as well as the
antibiotic azithromycin and the sleeping pill zolpidem.
• Wockhardt is not the only Indian pharmaceutical firm to run afoul of the FDA.
• Other Indian companies that have received warning letters over the last several months include
Aurobindo, Dr. Reddy’s Laboratories, and IPCA

• India is not the only place that is coming under increased
scrutiny by the FDA.
• For years, the agency only had a few inspectors on the
ground in China.
• Now that there are more, they are discovering
shortcomings in Chinese
plants too.

What about China?
What about China?

What about China?

What about China?
• The FDA has recently sent a slew of warning letters to a number of
companies in recent months.
• Even brand name companies have been tainted. Pfizer’s Chinese
partner, Zhejiang Hisun, was accused of systemic problems
associated with “data manipulation.”

What about China?
Chinese Drug Imports from Problem Plants:
• In the last few years the FDA has increased the number of inspectors it has
on the ground in India and China.
• It hasn’t been easy. FDA inspectors have had a hard time getting visas to
enter China.
• Unlike the unannounced inspections that occur in the U.S., the FDA must
alert officials in China and India that they are coming well in advance of a
visit.

What about China?
• There has been out-and-out fraud, where companies have been found to
fabricate data.
• In other cases there has been poor quality in manufacturing.

What about China?
• In the case of one of China’s major drug exporters,
Hisun, the FDA revealed that there had been “broad
data manipulation” at its factory in Taizhou.
• The FDA conducted its inspection of Zhejiang Medicine Co’s Xinchang
Pharmaceutical Factory in Shaoxing, Zhejiang in June of 2015.
• The FDA in a warning letter said that the employees plant routinely
performed “unofficial analyses” that they they kept out of the official
quality control records for its APIs.

What about China?
• Shanghai Desano, which is working with GlaxoSmithKline’s ($GSK) ViiV
Healthcare, was inspected in May by the FDA, which criticized the facility for
conducting “unofficial” tests of drug batches that it kept out of its official
record.
• The FDA found 8,400 unofficial chromatographic analyses
at the Desano plant performed between 2012 and 2014.
• The company has acknowledged that some of those tests
related to out-of-spec test results.

What about China?
• In the case of Chongqing Lummy Pharmaceutical,
the FDA inspected two plants in March.
• The warning letter slams the drugmaker for
widespread and serious data manipulation of
batch analyses.
• It found that the company routinely retested
samples without justification and deleted raw
analytical data from computerized systems that
did not provide the results that were needed.

What about China?
• In one egregious case, the FDA said on March 4, 2016,
an analyst set the gas chromatography personal
computer clock back to make it appear as if testing
had been done in August 2015, 7 months earlier.
• The analyst then performed 5 injections to produce
falsified results for long-term stability for a finished
API lot, deleted four and reported only the results of
the final injection as passing in the quality-control
data package.
• That was the test the quality unit then relied on to
determine if the lot was within specification.

Cheap Drugs May Be No Bargain
• “Made in America” used to be both a sign of quality
and a source of pride.
• But Americans care much more about saving money. That’s why so many of
our consumer products—from clothes to electronics to toys—are coming
from China and other low-wage countries.
• We’ve learned the hard way that such products may not always meet safety
standards.
• Lead in toys, for example, has led to a number of recalls.
• Toothpaste contaminated with antifreeze alarmed Americans for a few
weeks, but not enough to change buying habits.

• Most people assume that their medicines are still made in America.
• Nothing could be further from the truth. Experts estimate that 80 percent of
the active ingredients in our prescription drugs come from abroad.
• Increasingly, this means India and China.
• The former head of China’s Food and Drug Administration was executed a
few months ago because he accepted bribes from the companies he was
supposed to be overseeing.

• Don’t count on our FDA to protect you, though.
• The U.S. watchdog agency doesn’t have the budget or the manpower to
inspect more than a handful of the hundreds of manufacturing plants in
Southeast Asia.
• This year the FDA only plans to visit 13 out of 714 drug firms in China.
• Often, FDA officials don’t even know where to look.
• Some senior FDA officers have said there are 2,100 companies that would
need inspection.
• The Government Accountability Office estimates that nearly 7,000
companies will export pharmaceutical materials into the U.S. in 2007.

• The intense competition among generic drug makers and their search for the
cheapest raw materials has driven the huge increase of imports.
• The same motivation drove pet food manufacturers to purchase wheat gluten
contaminated with melamine from China.
• We worry that the FDA cannot guarantee the safety of these inexpensive
pharmaceutical products any more than they could protect our pets.

• The FDA is still struggling with
safety issues.
• Until it is adequately funded so that it can monitor
ingredients from places as far away as China,
Americans will wonder about the safety of their
food and drug supply.

• Insurance companies often establish favorable
relationships with certain drug companies.
• That means that those firms’ medicines are included on the approved list,
while others are left off.
• If the doctor writes a prescription for a drug that is not on
the list, the co-pay can be $50 or more each month.
• In some cases, patients may have to pay for the entire cost
out of pocket.

• The new Medicare Plan D program providing
prescription drugs for senior citizens is full of such
pitfalls.
• An insurance company may have only one or two drugs in a particular
category.
• It’s a travesty when, instead of your doctor, bureaucrats who know nothing
about your specific medical history make decisions about the drugs you
should take.
• Individuals should use the medicine that works best for them, with the fewest
side effects.
• That does not always correspond to the insurance company’s objective to
save money at all costs.

• Generic drugs are frequently offered as a
solution to the high cost of prescription
medicine.
• They are supposed to be identical to their brand
name counterparts.
• But how good are they, really?

RyMat Inc.: A Look At Generic vs. Brand Pharmaceuticals

Empfohlen

Empfohlen

Weitere ähnliche Inhalte

Was ist angesagt?

Was ist angesagt? (20)

Andere mochten auch

Andere mochten auch (20)

Ähnlich wie RyMat Inc.: A Look At Generic vs. Brand Pharmaceuticals

Ähnlich wie RyMat Inc.: A Look At Generic vs. Brand Pharmaceuticals (20)

Mehr von Stuart Silverman

Mehr von Stuart Silverman (17)

Kürzlich hochgeladen

Kürzlich hochgeladen (20)

RyMat Inc.: A Look At Generic vs. Brand Pharmaceuticals