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Positron Emission Tomography
(PET) Drugs
Proposed CGMP Rule and Draft Guidance
Questions and Answers
1. What did FDA do today?
The FDA published for comment a proposed rule to
establish current good manufacturing practices for positron emission
tomography (PET) drugs (21 CFR, part 212). In conjunction with the
proposed rule, we are issuing for public comment a revised draft
guidance "PET Drug Products – Current Good Manufacturing Practice (CGMP)."
The draft guidance provides additional information about approaches
to comply with the proposed regulations, when they become final.
Neither the proposed rule nor the draft guidance are final at this
time. This means the proposed rule is not binding or effective.
After FDA evaluates the comments received on the rule and the
guidance, we expect to publish final versions of both documents.
2. What are PET Drugs?
PET drugs are radioactive drugs injected into
patients that create images that can be read with a special camera
called a PET scanner. PET images show the chemical functioning of an
organ or tissue, unlike X-ray, or MRI images that show only body
structure. PET imaging is useful for patients with certain
conditions affecting the brain and the heart as well as in patients
with certain types of cancer. PET drugs contain a very small amount
of radioactive material, similar to the material used in other
diagnostic procedures. One of the distinctive properties of PET
drugs is that, because of their short half-life, they must be
administered to patients within minutes or hours of being produced.
3. Why is FDA regulating PET drugs?
PET drugs were originally developed as a research
tool. Although PET drugs are generally subject to all of the
requirements of the Federal Food, Drug, and Cosmetic Act (the Act)
that apply to other drugs, historically they were not a great
priority for FDA. However, our (FDA's) regulatory interest in them
grew in the mid-1990’s when they began to be used in clinical
practice. Because of the short half-life of the radioactive material
contained in PET drugs and their method of production, PET drug
products pose special issues with regard to production and
distribution. Both FDA and PET drug producers felt that certain
provisions of the current good manufacturing practice regulations
applicable to other types of drugs were inappropriate for PET drugs.
In 1997, Congress passed the Food and Drug Administration
Modernization Act (Public Law 105-115). Section 121 of the
Modernization Act directs us to establish appropriate approval
procedures and CGMP requirements for PET drugs. Section 121 also
provides that FDA cannot require the submission of a new drug
application (NDA) or abbreviated new drug application (ANDA) for a
PET drug product until 2 years after we publish appropriate approval
procedures and a final rule establishing CGMP requirements for PET
drug products.
4. What is the difference between a rule and a
guidance?
Rules state binding requirements and are enforceable
in the courts. A guidance describes FDA’s current thinking on an
issue, recommending approaches which, if followed by industry, would
in our judgment meet the requirements set forth in the regulations.
Guidances do not establish legally enforceable rights or
responsibilities. They do not legally bind the public or FDA.
5. What is CGMP?
Current good manufacturing practice is a minimum
manufacturing/production standard that ensures the drug meets the
requirements of safety and has the identity strength, quality, and
purity it is supposed to have. CGMP covers items such as control of
ingredients used to make drugs, production procedures and controls,
recordkeeping, quality system, and product testing. 21 CFR parts 210
and 211 contain the CGMP for non-PET drugs, while proposed 21 CFR
part 212 will contain CGMP requirements for PET drugs.
6. Do the proposed rule and draft guidance apply
to PET dugs used in clinical investigations and basic research?
INDs are used to allow investigation of new drugs in
order to provide evidence of the drugs’ safety and effectiveness
(see 21 CFR, part 312). The proposed regulations and draft guidance
apply to all PET drugs, but draw a distinction for PET drugs that
are produced under an IND or with the approval of a Radioactive Drug
Research Committee (see 21 CFR § 361.1) and used in basic research.
The proposed regulation provides that for investigational and
research PET drugs, CGMP would be met by producing PET drugs in
accordance with Chapter <823> of the 2004 version of the United
States Pharmacopeia, "Radiopharmaceuticals for Positron Emission
Tomography–Compounding." All other PET drugs would have to comply
with the new regulations proposed for Part 212.
7. How many PET facilities are there?
At the time the proposed rule was drafted, there
were slightly more than 100 PET facilities. However, the number of
PET facilities has been growing rapidly.
8. In what types of establishments are PET drug
facilities located?
PET drugs may be produced in hospitals, academic
institutions, and independent commercial facilities.
9. What is FDA doing about developing special
approval procedures for PET drugs?
FDA previously issued a draft guidance on the
content and format of NDAs and ANDAs for the following PET drugs:
This guidance can be found at
http://www.fda.gov/cder/guidance/3453dft.htm. We solicited
public comment on this guidance and we are now preparing a final
version of this guidance which we plan to issue soon.
In addition, we greatly simplified the submission of applications
for these PET drugs by conducting an evaluation of the literature on
the safety and efficacy of these drugs for certain uses and
publishing those findings in the Federal Register of March 10, 2000
(65 FR 12999). As a result, applications for these drugs for these
uses do not need to provide new clinical data to support approval of
the application.
We believe these actions have greatly simplified the procedures for
obtaining approval for the vast majority of PET drugs that are
currently in use in clinical practice.
10. Were PET drug producers and the public given
an opportunity to comment on CGMP for PET drugs before the proposed
rule and revised draft guidance were prepared?
We worked closely with the PET community in
developing the proposed regulations and guidance. We provided many
opportunities for public input including the following:
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We presented our initial tentative approach to PET
drug CGMP requirements and responded to numerous questions and
comments about that approach at a public meeting on February 19,
1999.
-
We announced the availability of preliminary draft
regulations on PET drug CGMP requirements in the September 21, 1999,
issue of the Federal Register (64 FR 51274).
-
We held a public meeting to discuss the preliminary
draft regulations on September 28, 1999.
-
After considering the comments on the preliminary
draft regulations, we announced the availability of a preliminary
draft proposed rule on PET drug CGMP requirements in the April 1,
2002, issue of the Federal Register (67 FR 15344).
-
We also announced the availability of a draft
guidance on “PET Drug Products--Current Good Manufacturing Practice
for Positron Emission Tomography” on April 1, 2002 (67 FR 15404).
-
We held a public meeting to discuss the preliminary
draft proposed rule and draft guidance on May 21, 2002.
-
After considering the comments on the preliminary
draft proposed rule and the previous draft guidance we are now
issuing a proposed rule and a revised draft guidance on PET drug
CGMP requirements, and we are again seeking public comment.
11. How can I comment on the proposed rule?
You may submit written or electronic comments on the
proposed rule and draft guidance until [insert 90 days after date of
publication in the FEDERAL REGISTER]. Written comments should be
submitted to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Electronic comments should be submitted to
http://www.fda.gov/dockets/comments. Comments should be
identified with the docket number found in brackets in the heading
of the proposed rule or the notice of availability, as appropriate.
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Date created: September 15, 2005 |
