Pharmaceutical Industry will face multiple challenges in 2015. Scrutiny continues to intensify over the prices of new drugs and biotech therapies

1. A protester displaying poster for better healthcare reforms in the US
Challenges of Pharmaceutical Industry in 2015
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Ochre Media
Pharmaceutical Industry will face multiple challenges in 2015. Scrutiny continues to intensify over the
prices of new drugs and biotech therapies, while demand for drugs escalates more sales and effective
treatments for deadly diseases in the US and the world. The root cause is to pay more attention to the
needs of patients, who have proper insights into the personal impacts of new medicines and trade offs
in risks and benefits involved. Drug Manufacturing will be shaped by these trends in coming months.
Change of Politics: During the
recent overthrow of Democrats by
the Republicans there’s a sense
of change in the political scenario,
as they feel optimistic about
Republicans gain will create
collaborative environment in
Washington and the much needed
legislation will be enacted before
2016 Presidential elections by
putting the new policy initiatives
on hold. The primary debate over
federal budget involves proposals
to hike funding for the National
Institute of Health (NIH) and Food
and Drug Administration (FDA),
as well as emergency support for
research and treatment of Ebola
and other diseases. But outlays
may not be hiked drastically. All sides talk about ratify Tax reforms, including the renewal of tax credits
important to industry research and investments.
Leaders of the House Energy & Commerce Committee are moving forward with the legislation
promoting 21st Century cures. Committee Chairperson Fred Upton plans to issue a discussion draft in
order to move the bill through E&C committee in March so house can vote on it before the Memorial
Day. This will leave time for the Republicans controlled senate to approve similar legislations, with an
aspiration to advance the clinical trials, promoting digital medicine, attracting more young scientists into
biomedical research and providing incentives for developing new drugs and critical therapies.
Looming over these initiatives is the possibility that Supreme Court will rule against the Obamacare
subsidies that acts as reaching medical coverage to millions. Such decisions can curb demand for
prescription drugs and undermines the nation’s healthcare system.
Price factor & Cost effects: The involvement of Drug research, development, production and marketing
continues by the prescription of drug pricing, Health Insurers have launched an aggressive campaign
against the drug manufacturers to hold the line of prices, While Pharmaceutical manufacturers debate
with the Insurers and Pharmacy benefit managers for lightening prescribed drugs and boosting
coinsurance rates to shift more costs to individuals. Consumer suggests FDA to be more active in
veiling comparative studies that can regulate the drug value and continue to force the government to
seek lower prices for the medicines dispensed through Medicare, Medicaid and other Public Health
Programs.

2. Healthcare Insurers are stressing the need for proper pricing of drugs with Pharmaceutical
Companies
Prospects of better R&D in Public Private Partnership will yield higher results in Pharmaceutical Industry
Pipelines and Research Proclivities: Proper Analysis is required to streamline R&D facilities and
prospects for market
approval is more
required for new
therapies. At the same
time the costs of
Pharmaceutical R&D
continues to drop,
according to the latest
analysis by Tufts Center
for the Study of Drug
Development, which puts
the total cost of a new
drug at whopping $2.6
Billion. The distressing
revelation here is lack of
progress in bio-
pharmaceutical R&D
more efficient, by
lowering high failure
rates in experimental
programs and n
developing methods for
reducing the time and
complexity for clinical
research.
Public-Private Partnerships: For a better finance for R&D, Pharmaceutical companies, academic
institutes and the Government organizations has to work closer for better expertise and resource. Not
to profit organizations are working closer with the Pharmaceutical Companies to fund specific drug
development program, whilst Government is investing heavily on R&D activities for the cure of tropical
diseases such as Ebola and conditions that lack sufficient markets to attract private investments.
Broader partnerships will strongly improve the clinical research methods and the systems.

3. Pharmaceutical Quality: FDA has to be aggressive enough to maintain the drug quality by slamming the
pharmaceutical companies who are not meeting sufficient standards in drug manufacturing. As
manufacturers are focusing on new strategies to prevent and detect low quality and adulterated
products in order to protect the Pharmaceutical supply chains in the United States and rest of the world.
Most visible is the reorganization is underway in FDA as its setting up a new Center for Drug
Evaluation and Research that helps in maintaining the Pharmaceutical quality to better coordinate,
review and inspection of drugs.
Patient Centeredness: Efforts are underway to facilitate access to potentially lifesaving therapies have
brought patients to the forefront of important regulatory and research discussions involving assessment
of potential benefits in the face of increased or uncertain risks.
Source: pharmtech.com
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