13/14 - The pharmaceutical industry Flashcards
What type of Phamaceutical Industry?
•more DIVERSE medications, chemical drug products ”blockbusters”
•Blockbuster = >1BILLION IN SALES
“Discovery of important new medicines for patients by pharmaceutical and biotechnology research companies”
Research Intensive
TRADITIONAL
What type of Pharm Industry?
• ~50% from biotech
•Many TRADITIONAL Big Pharma Companies are SHIFTING TO BIOTECH
Research-Intensive
BIOTECH
Global Pharm Market
•Global spending on medicines ~ $1.1 trillion
Forecast to reach nearly $1.5 trillion by 2021
- *•US spending represents**
- *over a third of global pharma sales**
>1/3
Major Trade Association
for
BIG PHARMA
PhRMA
Pharmaceutical Research and Manufacturers of America
Research intensive
discovery or development of
Brand-Name / Innovator Drugs
- *Research-intensive pharmaceutical industry:**
- *positions of support**
THEY LOBBY FOR THESE THINGS
- •Modernizing drug discovery, development and approval:
- Innovative drug research
- Swift development and approval of safe and effective drugs
- Scientifically sound, efficient FDA approval
- •Broad patient access to medicines through a free market
- •Securing the pharmaceutical supply chain
- Promoting the value of pharmaceuticals in “value-driven health care”
-
•Health care liability reform
-
–FDA defense to punitive damages
- •Should NOT be SUED for whats in the drug. In the hands of Doctors/Pharmacist to know whats in the drug
-
–FDA defense to punitive damages
- •Strong intellectual property incentives
Brand-name pharmaceutical industry
oppositions:
what they OPPOSE / lobby AGAINST
- Restrictive formularies (Medicaid, hospital, managed care, etc.)
- Preferred drug lists
–But they DO LIKE DUR’s and things that protect the patient
•Prior authorization
•Limits on prescription reimbursement
•Price controls
Investigational New Drug Application (IND)
•What is this used for?
means by which a pharmaceutical company obtains permission
to ship an experimental drug across state lines
(usually to clinical investigators)
before a marketing application for the drug has been approved.
Drug Development TIME & COST
>10 YEARS
2.6 BILLION
for a NEW DRUG
includes FAILURES + CAPITAL expenses
PATENTS
Issued by the
US Patent Trademark Office = PTO
Patents expire 20 years from the date of filing
- but other factors AFFECT IT*
- *Exclusivity / Patent Term Restoration Activites / Court Challengs**
1984 Drug Price Competition and Patent Term Restoration Act
(Hatch-Waxman Act)
- *allowed patent holders to recoup some lost patent time**
i. e., extended effective patent life)
•Patent extension application
must be filed with the PTO
within 60 days of FDA approval of the drug product
How long can effective patent term be extended?
ONE HALF of the period in clinical Trails
+
ENTIRE PERIOD of FDA REVIEW
MAX OF 5 YEARS can be restored to patent
///
TOTAL patent live WITH the PATENT EXTENSION
MAX OF 14 YEARS from the product’s approval date
Exclusivity
SEPERATE
it is NOT ADDED
it is GIVEN UPON THE APPROVAL
exclusive marketing rights
granted by the FDA
upon drug approval (granted to NDA holder) and
can run concurrently with a patent or not.
During exclusivity period, no company can submit generic drug application
(abbreviated new drug application, ANDA) to FDA seeking approval of a drug product containing the new chemical entity
–No other company can submit a “generic” when it is under approval.
ANDA
Abbreviated New Drug Application
a
GENERIC DRUG Application given to the FDA
seeking approval of a drug product contianing
“new chemical entity”
Length of Market Exclusivity
New Chemical Entity = 5 YEARS
Novel Biologic = 12 YEARS
&
the FIRST SUCCESSFUL PATENT CHALLENGE
= 180 DAY EXCLUSIVITY
worth A lot –> first generic drug approved gets this
# Define: •(i.e., cellular and biomolecular processes), **usually involving living cells and proteins**
contain large, complex or long-chained proteins − unlike conventional drugs (which are small-molecule chemicals)
Many “specialty drug products”
Biopharmaceuticals
- •Granulocyte-colony stimulating factors
- •Recombinant growth factors
- •Interferons
- •Interleukins
- •Monoclonal antibodies
- •Recombinant hormones
- •Certain vaccines (e.g., Hepatitis B surface antigen)
- •Recombinant thrombolytics, anticoagulants
- •Blood factors (Factor VIII, Factor IX)
- •Others
BLA
- *BIOLOGICS License Application**
- similar to NDA*
only need 1 CLINICAL TRIAL vs NDA
•Similar position statements of other research-intensive pharmaceutical companies, except desire separate reimbursement methods for drugs and biologics
•Spends higher percentage on R&D
Biotechnology Industry Organization (BIO)
- *Major BP Trade Association**
- in comparison to PhRMA*
Represents biotech companies, universities, research institutions, state biotechnology associations and affiliates
Many Pharm Companies belong to
BOTH PhRMA & BIO
BIOSIMILAR
AKA = Follow-On Biologics /// Follow-On Proteins
- Biosimilar is a biological product demonstrated to be “highly similar’ to an FDA-licensed reference product
- Large molecules for follow-on biologics are difficult to characterize fully
•Proteins produced through complex manufacturing processes;
may be differences in safety/efficacy profiles
Purple Book
NEW BIOLOGICS & BIOSIMILARS
similar to the
Orange Book for Generics
The Generic Pharmaceutical Industry
Providing consumers with safe and effective, quality drug products
at low costs
- *Trade Association = GPhA**
- *Generic Pharm Association**
Generic Drug Review and
Approval Process
average of 41 MONTHS to approve a generic
•Applicant (pharmaceutical firm) submits an
abbreviated new drug application (ANDA)
or an abbreviated antibiotic drug application (AADA)
to obtain FDA approval
TREND of
US RX Market Share
By dollars =
- *brand name** > unbranded > branded
- *brand name makes the MOST money**
By volume
unbranded generics are MORE OFTEN DISPENSED
> brand name drugs > branded generics
Branded Generic
aka AUTHORIZED GENERIC
Made by the SAME COMPANY
as the INNOVATOR
or one of its sister companies
Generic Pharmaceutical Industry
positions of support:
•Promoting and expanding the free market forces in the pharmaceutical industry
•Reducing generic approval backlog
•Supply chain security
•Abbreviated FDA approval process for biosimilars
Generic Pharmaceutical Industry
Oppositions
- Slow FDA review times for ANDAs
- Brand name (research-intensive) drug industry efforts to extend patents, e.g., court challenge
- Other “evergreening” strategies by Big Pharma industry to delay market introduction of generics
- *•Requirement of ‘authorized generics’** = branded generic name
- CAN BE MADE even in the period of exclusivity*
•Restrictions on rights to settle drug patent disputes out of court
•Planning (macro) level
•Macro-level core functions:
assessment, policy development, and assurance
Micro = IMPLEMENTATIOn
