Frequently
Asked Questions and Other Information
Pharmaceutical
Products and Pricing:
• Where can I get current pricing information?
• Where can I get information about specific
products?
• Where can I get information on clinical
studies, articles, and original references?
Patent
Expiration of Pharmaceuticals:
• Where can I find a list of patent expirations?
Medication
Errors:
• What is a medication error?
• What precautions are taken to avoid
medication errors?
Guidelines for Pharmaceutical Promotion:
• What is the PhRMA Code on Interactions
with Healthcare Professionals and where can I obtain a copy?
• What is the Office of Inspector General
(OIG), Department of Health and Human Services (HHS), Guidelines
and where can I get a copy?
FOI
(Freedom of Information) Requests:
• What are FOI requests?
• How can I get information on competitive
submissions to the FDA and letters that the FDA sends to a
pharmaceutical company?
AMA
(American Medical Association) Style Guidelines:
• What are AMA Style Guidelines?
Pharmaceutical
Industry News and General Information:
• Where can I get up-to-the-minute news
and information?
Orphan
Drugs:
• Are orphan drugs approved drugs?
• How much do orphan drugs cost?
• Will my insurance company pay for the
orphan drug I need?
• Are orphan drugs approved faster than
other drugs?
Pediatric
Exclusivity:
• What is pediatric exclusivity for a
new drug application?
• How does a new drug qualify for pediatric
exclusivity?
• Where does the FDA publish information
about pediatric exclusivity?
Drug Regulatory Harmonization:
• What is the definition of drug regulatory
harmonization?
• Are there organizations that monitor
these activities?
Drug Information Sources:
• Where can I go to research specific
drug information?
Food
& Drug Administration Modernization Act: OffLabel
Promotion
• What were FDAMA guidelines for off-label
promotion and how has that changed due to subsequent case
law?
• How does the Washington Drug Letter
case impact activities of pharmaceutical manufacturers?
Pharmaceutical
Products and Pricing:
• Where can I get current pricing information?
Pricing
information can be purchased at the following sites:
•
Facts & Comparisons publishes MediSpan database products,
including PriceAlertTM, a monthly
pricing publication detailing over 1,700 items and approximately
13,000 NDCs (National Drug Codes).
The
pricing information includes the average wholesale price
(AWP) and generic equivalent average price (GEAP). It can
be ordered at http://www.drugfacts.com.
•
RED BOOK® is a source for prices on prescription drugs,
OTC items, and reimbursable medical supplies.
To
order a copy of RED BOOK®, a Medical Economics
publication, go to http://www.pdrbookstore.com.
•
Where can I get information about specific products?
Many pharmaceutical
companies have their own product web site; the URL address
is usually the name of the product.
Information
and links on specific products can also be found on the manufacturing
company’s website, as well as on the following sites
after registering to become a member:
•
The Physician’s Desk Reference:
http://www.pdr.net
• MedScape from WebMD: http://www.medscape.com
•
Where can I get information on clinical studies, articles,
and primary references?
PubMed
(http://www.ncbi.nlm.nih.gov/entrez/query.fcgi
or www.pubmed.gov) is
a free service of the National Library of Medicine and provides
a searchable database, abstracts, and journal articles dating
back to 1968.
Patent
Expiration of Pharmaceuticals:
•
Where can I find a list of patent expirations?
The Orange
Book (Approved Drug Products with Therapeutic Equivalence
Evaluations), http://www.fda.gov/cder/ob/default.htm
provides information on exclusivity and patent expiration
dates.
Medication
Errors:
•
What is a medication error?
A medication
error is any preventable event that may cause or lead to inappropriate
medication use or patient harm, while the medication is in
the control of the healthcare professional, patient, or consumer.
Such events
may be related to professional practice, healthcare products,
procedures, and systems including: prescribing; order communication;
product labeling, packaging, and nomenclature; compounding;
dispensing; distribution; administration; education; monitoring;
and use as per the National Coordinating Council for Medication
Error and Prevention (NCCMERP).
The NCCMERP
is an independent body comprised of 20 leading national healthcare
organizations responsible for meeting, collaborating, and
cooperating to address the interdisciplinary causes of errors
and to promote the safe use of medications.
They can
be contacted at http://www.nccmerp.org.
The Institute
for Safe Medication Practices (ISMP) is a non-profit organization
that provides education and information about adverse drug
events and steps to prevent these events from occurring. The
ISMP works with healthcare practitioners and institutions,
regulatory agencies, professional organizations and the pharmaceutical
industry that voluntarily supply this information. Independent
reviews are compiled by ISMP and shared with the Medication
Errors Reporting Program (MERP), the FDA, and pharmaceutical
companies whose products are mentioned in the reports. For
more information, visit http://www.ismp.org.
•
What precautions are taken to avoid medication errors?
The FDA’s
Center for Drug Evaluation and Research (CDER) is responsible
to help ensure the safe use of drugs it evaluates by identifying
potentially misleading trade names that may contribute to
problems in the prescribing, dispensing, or administration
of the product.
Because
early identification of a potential confusing proprietary
name is crucial, CDER reviews proposed names of new drugs
prior to approval of an NDA (new drug application) by means
of the Office of Post Marketing Drug Risk Assessment (OPDRA).
More information
on medication errors can be found on the following websites:
•
The Center for Drug Evaluation, Medication Errors
http://www.fda.gov/cder/drug/MedErrors/default.htm
•
National Coordinating Council for Medication Error and Prevention
http://www.nccmerp.org
•
The Institute For Safe Medication Practices (ISMP)
http://www.ismp.org/
Many pharmaceutical
companies, healthcare providers, managed care organizations,
pharmacy benefit managers, and individual products have web
sites that address medication errors.
Guidelines for Pharmaceutical Promotion:
•
What is the new PhRMA Code on Interactions with Healthcare
Professionals and where can I obtain a copy?
On April
18, 2002, the Pharmaceutical Research and Manufacturers of
America (PhRMA) Executive Committee voted to adopt a new PhRMA
Code on Interactions with Healthcare Professionals.
The voluntary
code outlines guidelines for how sales representatives and
others involved in marketing pharmaceuticals should interact
with healthcare professionals. The code allows for informational
presentations and discussions that have a scientific and/or
educational benefit, without including entertainment or recreational
activities and must be modest to local standards.
These guidelines
went into effect on July 1, 2002 and can be found at http://www.phrma.org/mediaroom/press/releases/19.04.2002.390.cfm.
• What is the Office of Inspector General
(OIG), Department of Health and Human Services (HHS), Guidelines
and where can I get a copy?
The OIG/HHS
guidelines were drafted to offer suggestions and voluntary
guidance for pharmaceutical companies to create an internal
compliance program. The suggested program contains seven elements
to monitor and regulate internal procedures: (1) implement
written policies and procedures; (2) designate a compliance
officer and committee; (3) conduct training and education;
(4) develop effective lines of communication; (5) conduct
internal monitoring and auditing; (6) enforce standards through
publicized disciplinary guidelines; and (7) respond promptly
to problems and undertake corrective actions.
To view
the guidelines, visit: http://www.oig.hhs.gov/fraud/docs/complianceguidance/draftcpgpharm09272002.pdf
FOI
(Freedom of Information) Requests:
•
What are FOI requests?
The Freedom
of Information (FOI) Act allows public access to certain documents
and information in the public domain.
Certain
documents that are prepared for public distribution, such
as press releases, consumer publications, speeches, congressional
testimony, etc. can be found on the FDA website at http://www.fda.gov/cder/foi/index.html
If the
information you need is not online, you can submit an FOI
request. For guidelines on how to submit a FOI request, see
http://www.fda.gov/opacom/backgrounders/foiahand.html
The FOI
office tries to respond to all requests within 20 business
days.
•
How can I get information on competitive submissions to the
FDA and letters that the FDA sends to pharmaceutical company?
The FOI
Act allows you to request and receive information on competitive
submissions, including:
o New
Drug Applications (NDA)
o Abbreviated New Drug Applications (ANDA)
You can
also get warning, untitled, and violation letters issued by
the FDA’s Division of Drug Marketing and Communications
(DDMAC) and Center for Drug Evaluation and Research (CDER)
at http://www.fda.gov/cder/warn/.
District
office letters can be found at the main FDA Freedom of Information
Reading Room at http://www.fda.gov/foi/warning.htm.
You can customize the search by company, subject, issuing
office, and date.
AMA
(American Medical Association) Style Guidelines:
•
What are AMA Style Guidelines?
The AMA
Style guidelines are uniformed writing and editing guidelines
for medical-related writing. A copy of the AMA Style Guide
can be purchased directly from the AMA at http://www.ama-assn.org,
through http://www.amazon.com
or http://www.barnesandnoble.com,
or from any major bookstore.
The AMA
also has guidelines for web sites that are associated with
the AMA. These guidelines can be found at http://www.ama-assn.org/ama/pub/category/1905.html
Pharmaceutical Industry News and General Information:
•
Where can I get up-to-the-minute news and information?
There
are many pharmaceutical industry web sites and government
links that provide a wealth of information to keep you current
on industry news. A brief explanation of these web sites
follows:
Private and association sites:
BioSpace,
Inc. (http://www.biospace.com)
was developed to provide daily updates of industry-related
breaking news, press releases, feature articles, investor
news, job postings, and other information.
American
Association of Pharmaceutical Scientists (AAPS) (http://www.aapspharmaceutica.com),
a society of more than 10,000 scientists employed in academia,
industry, government and other research institutes worldwide,
hosts this website, which provides headline industry news
and biweekly pharmaceutical reports on various sectors of
the industry.
American
Medical Association (AMA) (http://www.ama-assn.org),
the nation’s leader in promoting professionalism in
medicine and setting standards for medical education, practice,
and ethics, provides weekly medical news and features.
Consumer
Healthcare Products Association (CHPA) (http://www.chpa-info.org),
represents US manufacturers and distributors of nonprescription,
over-the-counter (OTC) medicines and dietary supplements,
and provides comments to the FDA about the non-prescription
drug industry. Their site provides new releases, NDAs for
approved OTC products, and more.
Generic
Pharmaceutical Association (GPhA) (http://www.gphaonline.org).
The association of generic pharmaceutical manufacturers
provides consumers with information about the quality and
effectiveness of generic drugs and the savings that generics
provide to both individuals and the healthcare industry
as a whole.
Parenteral
Drug Association (PDA) (http://www.pda.org),
a non-profit international association of more than 10,000
scientists involved in the development, manufacture, quality
control, and regulation of pharmaceuticals and related products,
hosts a site that includes the latest scientific technical
and regulatory information on pharmaceutical and bio-pharmaceutical
manufacturing and quality worldwide.
Pharmaceutical
Research and Manufacturers of America (PhRMA) (http://www.phrma.org),
represents the country’s leading research-based pharmaceutical
and biotechnology companies devoted to inventing medicines
that are leading the way in the search for new cures. Their
site provides current issues, news, and resources for consumers
to get information about the pharmaceutical industry.
Government
web sites and links:
Food
and Drug Administration (FDA) (http://www.fda.gov),
the government agency that promotes and protects the public
health by helping safe and effective products reach the
market in a timely fashion, and monitors products for continued
safety after they are in use, posts their news releases,
meetings, speeches, safety alerts, product approvals, reference
room, hot topics, and other FDA activities on their site.
Center
for Biologics Evaluation and Research (CBER) (http://www.fda.gov/cber),
a part of the FDA, CBER protects and enhances public health
through the regulation of biological products, including
blood, vaccines, therapeutics, and related drugs and devices
according to statutory authorities. The regulation of these
products ensures their purity, potency, safety, efficacy,
and availability.
This
site provides product information, manufacturers’
assistance, health professional assistance, consumer information,
a reading room, and more.
Center
for Drug Evaluation and Research (CDER) http://www.fda.gov/cder
a part of the FDA, CDER promotes and protects the health
of Americans by assuring that all prescription and over-the-counter
drugs are safe and effective. CDER evaluates all new drugs
before they are sold, and serves as a consumer watchdog
for the more than 10,000 drugs on the market to be sure
they continue to meet the highest standards.
This
site provides news, new consumer information, NDA drug information,
regulatory guidance, and more.
As of
October 1, 2003 the FDA reassigned certain product oversight
responsibilities from the Center of Biologics Evaluation
and Research (CBER) to the Center for Drug Evaluation and
Research (CDER). The reorganization includes:
CDER
Office of New Drugs: Office of Drug Evaluation VI
Division
of Therapeutic Biological Oncology Products (DTBOP)
Division of Therapeutic Biological Internal Medicine Products
(DTBIMP)
Division of Review Management and Policy (DRMP)
CDER
Office of Pharmaceutical Science: Office of Biotechnology
Products
Division
of Monoclonal Antibodies (DMA)
Division of Therapeutic Proteins (DTP)
Department
of Health and Human Services – Government Information
Locator Service (GILS) (http://www.hhs.gov/oirm/gils/)
is a decentralized collection of agency-based information
locators using network technology and international standards
to direct users to relevant information resources within
the Federal Government.
Orphan
Drugs:
•
Are orphan drugs approved drugs?
Orphan
drugs (and biologicals) can either be approved or still in
the experimental phase. The Office of Orphan Products Development
at the FDA will classify a drug as an “orphan”,
thereby qualifying the sponsor to receive certain benefits
from the Government in exchange for developing the drug.
•
How much do orphan drugs cost?
The cost
of an orphan drug is decided by the sponsor and not by the
FDA and therefore, costs can vary.
•
Will my insurance company pay for the orphan drug I need?
Reimbursement
policies are designated by the insurance companies and differ
by policy. Generally, insurance companies will provide reimbursement
for an orphan drug that has been approved for marketing, but
tend not to reimburse for those still in the experimental
phase.
•
Are orphan drugs approved faster than other drugs?
The time
to receive an approval for an orphan drug has been significantly
shorter than other drug approvals because generally, an orphan
drug is developed to treat a serious or life-threatening illness.
For more information about orphan drugs, visit http://www.fda.gov/orphan/faq/
Pediatric
Exclusivity:
•
What is pediatric exclusivity for a new drug application?
Signed
by President Clinton in 1997, the Food and Drug Administration
Modernization Act (Section 505A) allows marketed prescription
product to receive an additional 6 months of exclusivity,
if in accordance with the requirements of the statute, the
sponsor submits requested clinical data on the use of the
compound in the pediatric population (defined as up to 16
years of age).
•
How does a new drug qualify for pediatric exclusivity?
In order
to qualify for exclusivity, a new drug application must (1)
receive a written request from the FDA, which includes in
detail the studies needed and the time frame allowed for completion;
(2) submit study reports after receipt of the written request.
The FDA will determine if the studies submitted meet the terms
of the written request; and (3) meet the specific conditions
of the written request including the time frame designated
and the criteria set forth by the FDA.
•
Where does the FDA publish information about pediatric exclusivity?
The FDA
publishes pediatric exclusivity information in the Patent
and Exclusivity Information section of the Orange Book (http://www.fda.gov/cder/ob/default.htm)
with updates and changes located at http://www.fda.gov/cder/orange/default.htm.
Drug
Regulatory Harmonization:
•
What is the definition of drug regulatory harmonization?
Drug regulatory
harmonization was established to streamline drug regulation
requirements and guidance documents in the Pan American Region.
The participating countries guarantee the safety, efficacy,
and quality of their pharmaceutical products and work together
to establish similar regulatory systems.
•
Are there organizations that monitor these activities?
Yes, the
Pan American Health Organization (PAHO; http://www.paho.org)
and the World Health Organization (WHO; http://www.who.org)
work together to promote quality in the production, distribution
and use of pharmaceutical products.
Drug
Information Sources:
•
Where can I go to research specific drug information?
•
Created by the National Library of Medicine, MEDLINEplus (www.nlm.nih.gov/medlineplus/druginformation.html)
provides up-to-date health information on prescription and
non-prescription drugs, diseases/conditions, hospitals and
physicians, a medical encyclopedia and dictionary, and links
to other websites.
•
The Food & Drug Administration supplies news on consumer
drug information at www.fda.gov/cder/consumerinfo/default.htm
and warnings, recalls, and other drug information at http://www.fda.gov/cder/drug/default.htm.
•
Information on drugs in clinical trial can be found at http://www.clinicaltrials.gov.
•
The Drug Information Association (DIA) (http://www.diahome.org)
is a multidisciplinary, international association of professionals
in the pharmaceutical and related industries. The mission
of the organization is to “provide a neutral, global
forum that promotes the exchange of information critical to
their professional performance and achievement.”
DIA publishes
the Drug Information Journal, a quarterly, peer-reviewed scholarly
journal that provides timely information on pharmaceutical
and biotechnology products and devices and provides a forum
to share ideas and research through communications among readers.
Food
& Drug Administration Modernization Act (FDAMA): Off-Label
Promotion:
•
What were FDAMA guidelines for off-label promotion and how
has that changed due to subsequent case law?
The Food
& Drug Administration Modernization Act (FDAMA) of 1997
(section 401) states that a manufacturer could only disseminate
off-label information while adhering to strict limitations
including (1) a manufacturer must submit, within 60 days,
a new drug or device application and (2) provide economic
information to formulary committees, managed care organizations,
and large scale buyers of healthcare products. It does not,
however, allow for the dissemination of economic information
that could have an effect on prescribing choices.
On July
28, 1999, the U.S. District Court for the District of Columbia,
ruled that based on the first amendment right to free speech,
it is unconstitutional for the FDAMA or the FDA to restrict
or prohibit a pharmaceutical or medical device manufacturer
from (1) disseminating information to a medical professional
that has appeared in a bona-fide peer-reviewed journal or
reference textbook or compendium; and (2) recommend content
or speakers to an independent program provider in connection
with a continuing medical education seminar or symposium regardless
of discussions that might be off-label. The ruling has been
named the Washington Drug Letter case. Based on this case
law, to participate in the dissemination of off-label promotion,
the manufacturer must confirm that the product has already
been FDA-approved for at least one use and that the off-label
information is not false or misleading.
•
How does the Washington Drug Letter case impact activities
of pharmaceutical and device manufacturers?
The decision
is a victory for pharmaceutical and device manufacturers who
need to provide timely and accurate off-label information
to medical professionals. It also combats the over-regulation
of promotion and advertising of pharmaceuticals and medical
devices by the FDA. However, actual off-label promotional
activities vary dramatically by company.
For further
information about the Food & Drug Administration Modernization
Act of 1997, visit http://www.fda.gov/oc/fdama/default.htm.
For further
information about the Washington Drug Letter case, visit http://www.wlf.org/upload/7-29-99henney.pdf.
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