Product Marketing and Handling Complaints

The pharmaceutical industry is comprised of companies engaged in researching, developing,

manufacturing and distributing drugs for human orveterinary use. The industry comprises different
subfields pertaining to the development, production, and marketing of medications. These more or less
interdependent subfields consist of drug manufacturers, drug marketers, and biotechnology companies.
The main goal of the pharmaceutical industry is to provide drugs that:
1. prevent infections,
2. maintain health, and
3. cure diseases.
Drug therapy is now an integral part of nearly every facet of healthcare, and new breakthroughs
promise to revolutionize the treatment of non-communicable diseases. This industry directly affects the
global population, so a number of international regulatory bodies monitor things like drug safety, patents,
quality, and pricing. Here are some of those regulatory entities:
World Health Organization (or WHO)
US Food and Drug Administration (or FDA)
Medicines and Healthcare Products Regulatory Agency (or MHRA)
Pharmaceuticals(or drug, medicine)
-are defined as any substance intended for use in the diagnosis, cure, mitigation, treatment or
prevention of disease or any substance (other than food) intended to affect the structure or function
of the body.
- refers to innovative and generic products, chemically-derived and biologically-derived
products, and prescription-basedand over-the-counter products.
Innovative (originator) chemically-derived drugs are developed through extensive R&D and
clinical trials in both humans and animals.
Generic drugsare copies of innovative pharmaceuticals that contain the same active ingredients
and are identical in strength, dosage form and route of administration
Biologics (biotech drugs, biological drugs, biopharmaceuticals)include a wide range of products
such as vaccines, therapeutic proteins, blood and blood components, tissues, etc.
Biosimilars (follow-on biologics)are versions of biologic products that reference the originator
product in applications submitted for marketing approval to a regulatory body.
Over-the-counter (OTC) drugs are distinguished from innovative and generic drugs in that
consumers do not need prescriptions to purchase them
Active pharmaceutical ingredients (APIs) and excipients are ingredients in a medication. APIs are
the compounds that make drugs effective
Global needs drive growth of pharmaceutical industry
Aging population
Worldwide, the average human life span has increased substantially over the last few decades. However,
more infections and diseases have come along with this longevity growth. This has led to increased
research on aging populations. The goals are to prevent infections and maintain health so that these
populations can enjoy better lives.
Changing lifestyles
Hectic daily schedules have led to unhealthy eating habits, a lack of exercise, less sleep, and other
problematic lifestyle choices. This has resulted in high obesity rates, poor digestion, hallucinations,
breathing difficulties, and other physical problems. Health supplements have been introduced to remedy
all of these issues, reduce the chance of getting sick, and meet daily nutritional needs through vitamins
and minerals.
Increased income and chronic diseases
The middle class has been growing in both the emerging and developed markets. People in these markets
have more disposable income and expect better healthcare solutions. Chronic disease cases have risen
in number. This has made people become more dependent on medications and health supplements.
Other economic trends
Globalization and urbanization have led to increased environmental disturbances. These are major
driving forces in the growing demand for improved medication and health supplements for each age
group and geographic location.
Industry players
Companies like Abbott Laboratories (ABT), Novartis AG (NVS), GlaxoSmithKline (GSK), and Teva
Pharmaceutical Industries (TEVA) are constantly looking at consumer needs and upgrading drugs based
on research and innovation. All four of these companies are part of the VanEck Vectors Pharmaceutical
ETF (PPH).
Classification of pharmaceutical subindustries
Drug manufacturing
Drugmakers include API (active pharmaceutical ingredients) and formulations manufacturers.
These companies make the following types of drugs:
APIs. These are the raw materials used to manufacture drugs. Generally, large setups make
APIs because these capital-intensive materials require special environmental conditions.
Generic drugs. Companies sell these off-patented, cost-effective drugs at low prices using no
specific brand name in order to serve the public. Abbott Laboratories (ABT), Actavis plc (ACT),
and many other pharma companies make generics.
Patented drugs. Companies develop these drugs through in-house research or licenses from
other firms and then manufacture the drugs under licenses from patent holders. Patented
drugs have high profit margins. Pfizer Inc., Merck & Co. (MRK), Sanofi, GlaxoSmithKline, Teva
Pharmaceutials (TEVA), and many others make patented drugs.
CRAMS (contract research and manufacturing services). Companies that provide these
contract services conduct research and manufacture drugs under licenses from other
companies.
Drug marketing
Marketing companies in the pharma industry help increase the market reach of drugs. At times,
a manufacturing company cannot sell its product in a specific region because the company lacks a
license or marketing network to do so. This is where drug marketing companies come in to facilitate
sales.
Biotechnology and R&D
Pharmaceutical companies are either dependent on their in-house R&D centers, or they rely on
biotechnology companies to provide them with licenses to manufacture patented products.

PHARMACEUTICAL INDUSTRY SUPPLY CHAIN

TOP MARKETS AND METHODOLOGY
Pharmaceutical Marketing is the business or otherwise promoting of pharmaceutical drugs.
Ad Spending / Advertising Budget - This is the amount of money a company is willing to pay in
order to promote its products to the public.
Common pharmaceutical products advertised
Food supplements
Antibiotics
Antihistamines
Antidiarrheal medications
Antidepressants
Stimulants
Analgesics
MODES OF ADVERTISEMENTS
Traditional marketing this is a strategy where companies distribute free drug samples to
physicians and doctors. These doctors then promote these drugs to their patients.
Digital Advertising/Internet advertising advertising with the use of Internet technologies
to deliver promotional advertisements to customers. Digital advertising includes promotional
advertisements and messages delivered through email, social media websites, online advertising
on search engines, banner ads on mobile or Web sites and affiliates programs.
Television advertising
Radio advertising
Newspaper advertising
Event sponsorship

INDUSTRY OVERVIEW AND COMPETITIVENESS

Global Competitiveness in the Pharmaceutical Industry makes several theoretical, empirical, and
methodological contributions which lead to results and generate important managerial and public
policy implications
Global Competitiveness in the Pharmaceutical Industry recognizes pharmaceutical industries as
being of great social and public importance to all countries, since so many lifesaving drugs have
emerged from pharmaceutical laboratories over the past four decades.
In 1991, the U.S. International Trade Commission (the Commission) conducted a study on the
pharmaceutical industry, Global Competitiveness of U.S. Advanced-Technology Manufacturing
Industries: Pharmaceuticals, as part of a series on global competitiveness of U.S. advanced-
technology manufacturing industries requested by the Senate Committee on Finance.
Economic impact
Large, diversified and global, the U.S. pharmaceutical industry is one of the most critical and
competitive sectors in the economy.
Pharmaceutical Research and Manufacturers Association (PhRMA) - more than 810,000 people work
in the biopharmaceutical industry in the United States across a broad range of occupations, such as
scientific research, technical support and manufacturing. Directly and indirectly, the industry supports
over 3.4 million jobs across the United States and added an estimated
Research and development (R&D)
The pharmaceutical sector has consistently been one of the most R&D intensive industries in the
United States. The research-based industry generally allocates around 15 to 20 percent of revenues to
R&D activities and invests over $50 billion on R&D annually.1
Trends
The pharmaceutical industry is complex, dynamic, and highly globalized, with many
pharmaceutical companies operating in multiple countries.1
Adding to the international nature of the industry, there is a continued trend toward outsourcing
Continues to be characterized by high R&D expenditures and extensive regulation of its products
compared with other manufacturing sectors.
Fast growing segments of the pharmaceutical market include biologics and generics
 The innovative pharmaceutical industry is currently facing unprecedented challenges caused by
slower sales growth, expiring patents, increasing competition from generics, shorter product life
cycles, tighter regulations, adverse media coverage and reputational damage, and a decline in
the number of new innovative drugs under development
The industry is adjusting to a more competitive environment by shifting manufacturing and other
operations overseas, revamping research pipelines, reducing employment, particularly in sales
but also in manufacturing and research, and organizing mergers and acquisitions (M&As).
GLOBAL INDUSTRY LANDSCAPE
The worldwide market for pharmaceuticals is projected to grow from around $1 trillion in 2015 to
$1.3 trillion by 2020, representing an annual growth rate of 4.9 percent. Several global demographic
and economic trends are driving pharmaceutical consumption, including a rapidly aging world population
and an associated rise in chronic diseases, increased urbanization and higher disposable incomes, greater
government expenditure on healthcare and growing demand for more effective treatments.
Developed markets
The primary pharmaceutical export markets in the near-term will continue to be in the traditional
strongholds of North America, Western Europe and Japan, which have high per capita spending rates on
healthcare, strong IP protections and streamlined regulatory processes.
Growth rate challenges:
Stagnating national economies
Tighter regulations
Patent expiries
Pricing pressure
Developing markets
Market growth is shifting toward emerging markets in Asia, Latin America and elsewhere, where
pharmaceutical sales are forecast to expand at double digit rates. Further reforms of legislative systems,
especially regarding patent protection and enforcement, as well as improving regulatory conditions, will
make these markets increasingly attractive for U.S. industry.

CHALLENGE AND BARRIERS IN MARKETING

Regulatory approval
Differences in regulatory approval requirements can lead to duplicative testing and clinical
trial requirements, delays in product approval and higher costs to manufacturers.
Patent approval
Patent backlogs and long, uncertain approval timelines are common problems
worldwide. Because the term of a patent usually begins on the date an application
is filed, approval delays can greatly reduce the value of granted patents. This
is especially concerning to smaller firms, which tend to be more dependent on their
intellectual property assets.
Patentability
Whether through regulations or court decisions, many countries prohibit patents
on important pharmaceutical innovations, such as new dosage forms or combinations
that make it easier for patients to take medicines. Such incremental innovations
are often essential for advancing treatments and add enormous value to patients.
Data supplementation in patent applications
In consideration of the time and expense required to gather data on pharmaceutical
inventions, it is best practice for reviewing bodies to permit applicants to file
supplemental data after a pharmaceutical patent application is submitted.
Patent enforcement
An effective IP system should offer patent holders strong enforcement tools for
defending against infringement. Such tools include patent linkage provisions, which give
companies the opportunity to dispute infringing patents before they enter a market
and damage their business.
Compulsory licensing (CL)
CL refers to when a government allows someone else to produce a patented
product or use a patented process without the consent of the patent holder. It
is one of the flexibilities on patent protection included in the TRIPS Agreement, which
lists required conditions for issuing compulsory licenses, including non-exclusive nature,
 limited scope and duration, a right to remuneration that must be adequate and so
on.
Regulatory data protection (RDP)
RDP complements patent rights by providing innovative companies protection for
a limited duration against disclosure and unfair commercial use of the safety and
efficacy data submitted to drug regulatory authorities.
Pricing
Naturally, pricing is of paramount concern to pharmaceutical manufacturers.
Artificially depressed prices set by governments can ultimately cripple drug supplies
and reduce incentives for further investment in a market.
Localization
Some trading partners, potentially in an effort to protect or develop their own
domestic industry, limit or ban certain imported pharmaceuticals.
Tariffs
Foreign tariffs, taxes and other fees also present significant market access
barriers to U.S. pharmaceuticals. Not only do such expenses unnecessarily increase
drug costs to patients, but they also often slow product delivery due to U.S.
companies having to make payment on and credit complying transactions.
Counterfeits
A counterfeit drug is a pharmaceutical product that is produced and sold with the
intent to deceptively represent its origin, authenticity or effectiveness. It may contain
inappropriate quantities of active ingredients (or none at all), may cause bodily
harm, may contain ingredients that are not on the label or be supplied with
inaccurate packaging and labeling.
HANDLING COMPLAINTS
Product complaint is a topic of interest for all the pharmaceutical companies, medical device
manufacturers, consumer healthcare companies and various other industries governed by regulatory
authorities.
Complaints Management forms the Consumer Management. A properly executed complaints
management program, can:
decrease customer maintenance costs,
increase revenues, and
improve a companys ability to track historical customer and product trends which are
useful to forecast future market, product, and customer needs
Pharmaceutical industry is diverse and includes nearly any physical product used in the health
care industry making complaints management hard to manage. This also makes ensuring compliance
with government regulations a difficult task. Documentation is critical and attempting to ensure a
tightly-managed process in the business environment can be very complex and expensive.
Effective complaint management solution is needed due to this ff. points
Insufficient product complaint handling was and still one of the top FDA findings in published 483
warning letters.
- Failure to have written procedures that describe drug product complaint handling
- Failure to have adequate complaint procedures for adverse drug experiences
- Failure to establish and follow adequate procedures for handling and investigating
complaints regarding product quality
- Failure to determine a need for an investigation and failure to conduct investigations
- Failure for presenting a complaint file and appropriate investigations of complaints
conducted
- Not adequate clarity around what ca be reported as an adverse event and what not
- Inadequate integration with CAPA systems and regulatory processes
Regulatory and competitiveness pressures are forcing organizations to change their product
complaint management strategy.
Dynamic and stringent regulatory landscape is making it mandatory for organizations, to
track, record and report all complaints with respect to the product quality and safety; and to
take appropriate follow-up actions to prevent reoccurrence of such incidents.
STEP BY STEP SOLUTION TO THE PROBLEM
The solution should include real-time visibility to track each product compliant through its life
cycle.
The solution should be easily configurable to support the variety of users involved in the complaint
management lifecycle.
The solution should be easily integrated with the other quality management processes that are
critical for regulatory compliance such as change control, audit management, and CAPA.

Basic Work Flow and product Complaint Handling in Pharmaceutical

Salient Features of Good Complaint Management Solution

1. Functionality breadth and depth
2. Standardized and automated system
3. Safety and security of system
4. Performance of solution
Exploring the solution further
In this solution, the following functionalities should be covered, at various stages of Complaint
Management process:
Receipt:
Data and Complaint Management
Routing and escalation
Task management
Processing and Reporting
User Management
How the Solution solves the Problem
The robust Complaint Management solution provides both processes and technology for gathering,
classifying, and preserving product information in order to anticipate, diagnose, and resolve product-
related problems. It offers direct access to specific product details that allow quick problem resolution,
and a web-based entry and status reporting system for customer service. Triggers can alert Quality
personnel to critical or recurring customer reports for specified products. Such alerts are invaluable for
enabling quick defect-correction and customer notification before a problem becomes widespread.
This solution should be driven by specific ROI levers including reduced warranty costs, mitigation of
regulatory fines, reduced refund/return error owing to accurate information, and reduced cost of
compliance. The solution also results in reduced costs of compliance through minimum time and costs of
processing complaints, uniform compliance, and a high quality of content among all partners.

With this solution, companies can look forward to getting the following benefits:
 Standardized, consistent and complete global complaint handling process and data collection.
Increased data consistency and enhanced reporting capability.
Increased customer loyalty through improved response time.
Increased security with Part 11 compliance.
All complaints captured in one single database.
Complaint data consistency.
Standardized process can be rolled out globally, within short time frame.
Conclusion
Complaints management is a complex problem in a unique industry, and the issue promises to
remain critical in the future. As regulatory and market pressures continue to mount upon
pharmaceutical companies, industry leaders will need to develop effective solutions or face the high
costs inherent in failed technology implementations, FDA censure, and weak customer relationships.
The preferred alternative is a customer-focused complaints management solution that works.

ISSUES IN PHARMACEUTICAL MARKETING

Johnson & Johnson Faces Pharmaceutical Decline
- The U.S. pharmaceutical industry is faced with challenges on pricing and regulation. This had led
many companies to underperform.
-Johnson & Johnson faced significant problems with currency fluctuations this year.
- I believe that, due to headwinds in the immunology business, J&J will underperform the market
in 2017.

Pfizer tried to push through a $118 billion acquisition of U.K.-based Astrazeneca

- Pfizer makes a 59bn offer to AstraZeneca when they meet for talks. It comprises 1.758
shares plus 13.98 cash per AstraZeneca share, a 70pc/30pc split
- AstraZeneca tells Pfizer it needs to increase its offer by at least 10pc to win board
recommendation. Talks end, but then Pfizer goes public with a 'final' offer for AstraZeneca at 55
per share, valuing the Anglo-Swedish company at 69bn.

Valeant and Allergan Case

- Valeant Pharmaceuticals International Inc has teamed up with Pershing Square Capital
Management, led by activist investor William Ackman, to make a run at Botox maker Allergan Inc.
- Allergan rejects Valeants raised offer again.

Amarin Vs. FDA lawsuit

- Amarin sued the FDA to promote the drug Vascepa, as a off label drug.
- Amarin proposes statements and disclosures to maake doctors truthful and non-misleading