Regulate biologic products, their manufacture and ... - KansasBio

clatteringlippsBiotechnology

Dec 5, 2012 (4 years and 6 months ago)

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Federal Regulations and
Industry Stewardship of PMPs

Dr. Michael J. Phillips

Vice President, Food and Agriculture, Science and Regulatory Affairs

Biotechnology Industry Organization, Washington, D.C.

May 31, 2006

BIO represents more than 1,100 biotechnology
companies, academic institutions, state biotechnology
centers and related organizations across the United
States and 31 other nations. BIO members are
involved in the research and development of
healthcare, agricultural, industrial and environmental
biotechnology products.


Biotechnology Industry Organization (BIO)

1225 Eye Street, N.W., Suite 400

Washington, D.C. 2005

202.962.9600

www.bio.org



About BIO


USDA APHIS:

Regulate plant growth,
definition of appropriate safeguards for
regulated products, transport of
product constituents


FDA CFSAN & CVM:
Consultation on
food and feed safety


FDA CBER/CDER:

Regulate biologic
products, their manufacture and
distribution



PMP Companies:
Safety Assessments,
Drug Master Files, Chemistry
Manufacturing Controls & Biologics
License Agreement for client’s drug
registration, Field Production; CACCP
Plan


FDA :

USDA & FDA:

Regulatory Pathway for Plant
-
Made
Pharmaceuticals Is Defined

Gene

Plant

Field

Harvest


Grind


Extract


Clarification


Chromatography

Regulating PMP Field Production

Permit

Application

Received

Scientist

Reviews

Deficiencies
Identified &

Applicant Responds

Permit
Complete

Successfully

Unsuccessfully

Letter, Permit &
Proposed
Conditions Sent to
the State

State Adds
Conditions

& Concurs

State
Denies

Permit

Denied

Permit Issued

with Conditions

Plant
-
Made Pharmaceutical Permit Process

Industry Self
-
Regulation: CACCP

CACCP Plan


Containment Analysis and Critical Control Point Plan


Developed in 2003 by BIO and its members


Created with input from the Food Products Association, Grocery
Manufacturers Association, the National Corn Growers
Association, and the North American Millers Association


Ensures compliance with federal regulations for the
confinement of PMPs


Identifies potential hazard points and develops
confinement strategies for those points


Modeled on the Hazard Analysis and Critical Control
Points (HACCP) approach used in the food and
pharmaceutical industries



7 Principles of CACCP


Conduct loss of containment analysis


Determine critical control points


Establish critical limits


Establish monitoring procedures


Establish corrective actions


Establish verification procedures


Establish record keeping and documentation


Consumer Questions

Are PMPs safe?


As plants, they are grown under strong permit regulations
and monitored by USDA


Therapeutic proteins, once extracted for use in
pharmaceuticals, are regulated and approved by FDA,
similar to other biopharmaceuticals


Strict confinement measures ensure that food and feed
supply do not commingle with PMPs


Consumer Questions

How are PMPs different from biotech crops?


PMPs are not value
-
added opportunities for agriculture or many
growers


PMPs are not sold as seed to growers


PMPs are “production factories” and are one step in the
pharmaceutical manufacturing process


PMPs are handled completely outside of the commodity food
and feed stream


Commodity biotech crops are grown on hundreds of millions of
acres in the U.S.; in 2002, PMPs were grown on 130 acres in
the U.S.


Commercial Crop Biotechnology


Harness biotechnology to improve crops in an expedited
manner


these plants are specifically designed for food, feed,
and fiber use.


Over 100 million acres of biotech corn and soybeans grown
each year in the United States


No adverse health events in humans or animals from any
biotech crops


Regulated by three federal agencies: USDA, FDA, and EPA


Grown on over 200 million acres in 18 countries


Six major crops: corn, cotton, soybean, papaya, squash, and
canola




Is not

a commodity agricultural
production system:


Contained process


Outside commercial grain
channel


Limited acreage, location


Controlled articles


Grown and processed under
USDA permit conditions


Is
like any other pharmaceutical
production system:


Regulated and subject to
mandatory conditions


Well characterized


Stable


Productive


Produces safe, pure, potent,
consistent product

PMP Production

Plant
-
Made Pharmaceuticals


Used to manufacture therapeutic proteins, which
are extracted, refined and used in regulated
pharmaceuticals


Can only be grown under USDA/APHIS permit
conditions, and will never be de
-
regulated


APHIS and/or state officials inspect records,
facilities, and each field site is inspected at least
7 times over 2 years


Only a few select and trained growers under
contract, with APHIS approval, can grow PMPs


Most equipment that comes into direct contact
with must be dedicated for PMP production only
and cannot be used with any crops intended for
food, feed or fiber use


Confinement measures are based on the type of
plant, specific target protein, and location of
production area

Commodity Agriculture


Harvested food, feed, and fiber use


Permits only required for field trial
phase of biotech crops; after
federal approval is granted, no
permits are required


Inspections required for field trial
phase; once federal approval is
granted, no inspections are
required


Any farmer can plant biotech
crops


Hundreds of millions of U.S. acres
are planted with biotech crops


No dedicated equipment needed
for biotech crops


Confinement measures are only
needed during field trial phase

Commodity Crops vs. PMPs

Consumer Questions

Why are food plants used in PMP
technology?


Researchers have extensive agricultural knowledge and
familiarity with these plants, as well as experience with their
growth


Scientists have a vast understanding of genetics, agronomics,
and the environmental impact these plants have, as well as their
composition


Considerable knowledge is needed to confine and manage these
plants


Sometimes, these plants are best suited for the specific target
protein


Non
-
food crops are also used for protein production in plants


Consumer Questions

Will PMPs end up in the food supply?


USDA APHIS has set up strict confinement requirements that
are based on scientific risk assessments


Confinement measures include both spatial isolation and
temporal separation


Machinery used for PMPs is unique to these purposes and
cannot be shared with conventional crops


Comprehensive education programs for personnel working with
PMPs


BIO and its members have developed a Containment Analysis
and Critical Control Point (CACCP) Plan to identify hazards
and critical control points, and establish procedures for
maintaining these points

Consumer Questions

Why can’t the public know where PMPs
are grown?


Confidentiality: the location of fields is considered confidential
business information (CBI); this is not an unusual practice for
any industry


Safety: there is a history of vandalism by activists when field
trial locations are discovered


the safety of the plants, as well
as employees and growers, are at risk


No need: state and federal governments are familiar with the
locations and conduct regular audits to ensure that permit
requirements are followed



For More Information


www.bio.org