13/14 - The pharmaceutical industry

Question 1

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​”

Answer 1

Research Intensive

TRADITIONAL

Question 2

What type of Pharm Industry?

• ~50% from biotech

•Many TRADITIONAL Big Pharma Companies are SHIFTING TO BIOTECH

Answer 2

Research-Intensive

BIOTECH

Question 3

Global Pharm Market

•Global spending on medicines ~ $1.1 trillion

Forecast to reach nearly $1.5 trillion by 2021

Answer 3

• *•US spending represents**
• *over a third of global pharma sales**

>1/3

Question 4

Major Trade Association

for

BIG PHARMA

Answer 4

PhRMA

Pharmaceutical Research and Manufacturers of America

Research intensive
discovery or development of
Brand-Name / Innovator Drugs

Question 5

• *Research-intensive pharmaceutical industry:**
• *positions of support**

THEY LOBBY FOR THESE THINGS

Answer 5

• •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
• •Strong intellectual property incentives

Question 6

Brand-name pharmaceutical industry
oppositions:

what they OPPOSE / lobby AGAINST

Answer 6

• 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

Question 7

Investigational New Drug Application (IND)

•What is this used for?

Answer 7

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.

Question 8

Drug Development TIME & COST

Answer 8

>10 YEARS

2.6 BILLION
for a NEW DRUG
includes FAILURES + CAPITAL expenses

Question 9

PATENTS

Answer 9

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**

Question 10

1984 Drug Price Competition and Patent Term Restoration Act
(Hatch-Waxman Act)

Answer 10

• *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

Question 11

How long can effective patent term be extended?

Answer 11

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

Question 12

Exclusivity

SEPERATE
it is NOT ADDED
it is GIVEN UPON THE APPROVAL

Answer 12

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.

Question 13

ANDA

Answer 13

Abbreviated New Drug Application

a
GENERIC DRUG Application given to the FDA
seeking approval of a drug product contianing
“new chemical entity”

Question 14

Length of Market Exclusivity

Answer 14

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

Question 15

# 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”

Answer 15

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

Question 16

BLA

Answer 16

• *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

Question 17

Biotechnology Industry Organization (BIO)

Answer 17

• *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

Question 18

BIOSIMILAR

Answer 18

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

Question 19

Purple Book

Answer 19

NEW BIOLOGICS & BIOSIMILARS

similar to the

Orange Book for Generics

Question 20

The Generic Pharmaceutical Industry

Answer 20

Providing consumers with safe and effective, quality drug products
at low costs

• *Trade Association = GPhA**
• *Generic Pharm Association**

Question 21

Generic Drug Review and
Approval Process

Answer 21

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

Question 22

TREND of
US RX Market Share

Answer 22

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

Question 23

Branded Generic

Answer 23

aka AUTHORIZED GENERIC

Made by the SAME COMPANY
as the INNOVATOR
or one of its sister companies

Question 24

Generic Pharmaceutical Industry
positions of support:

Answer 24

•Promoting and expanding the free market forces in the pharmaceutical industry

•Reducing generic approval backlog

•Supply chain security

•Abbreviated FDA approval process for biosimilars

Question 25

Generic Pharmaceutical Industry
Oppositions

Answer 25

• 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

Question 26

•Planning (macro) level

•Macro-level core functions:
assessment, policy development, and assurance

Answer 26

Micro = IMPLEMENTATIOn