Challenges of Pharmaceutical Industry in 2015
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.
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.
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.
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