Government-funded biomedical research

Since the establishment of the National Institutes of Health (NIH) in the mid-1940s, the main source of U.S. federal support of biomedical research, investment priorities and levels of funding have fluctuated. From 1995 to 2010, NIH support of biomedical research increased from 11 billion to 27 billion  Despite the jump in federal spending, advancements measured by citations to publications and the number of drugs passed by the FDA remained stagnant over the same time span. Financial projections indicate federal spending will remain constant in the near future. # ISO certification in India

US federal funding trends

The National Institutes of Health (NIH) is the agency that is responsible for management of the lion’s share of federal funding of biomedical research. It funds over 280 areas directly related to health. Over the past century there were two notable periods of NIH support. From 1995 to 1996 funding increased from $8.877 billion to $9.366 billion, years which represented the start of what is considered the “doubling period” of rapid NIH support.^[8] The second notable period started in 1997 and ended in 2010, a period where the NIH moved to organize research spending for engagement with the scientific community. # ISO certification in India

Privately (industry) funded biomedical research

Since 1980 the share of biomedical research funding from industry sources has grown from 32% to 62%, which has resulted in the development of numerous life-saving medical advances. The relationship between industry and government-funded research in the US has seen great movement over the years. The 1980 Bayh–Dole Act was passed by Congress to foster a more constructive relationship between the collaboration of government and industry funded biomedical research. The Bayh Doyle Act gave private corporations the option of applying for government funded grants for biomedical research which in turn allowed the private corporations to license the technology. Both government and industry research funding increased rapidly from between the years of 1994–2003; industry saw a compound average annual growth rate of 8.1% a year and slowed only slightly to a compound average annual growth rate of 5.8% from 2003 to 2008. # ISO certification in India

Conflicts of interests

“Conflict of interest” in the field of medical research has been defined as “a set of conditions in which professional judgment concerning a primary interest (such as a person’s welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain).”

Regulation on industry funded biomedical research has seen great changes since Samuel Hopkins Adams declaration. In 1906 congress passed the Pure Food and Drugs Act of 1906. In 1912 Congress passed the Shirley Amendment to prohibit the wide dissemination of false information on pharmaceuticals. The Food and Drug Administration was formally created in 1930 under the McNarey Mapes Amendment to oversee the regulation of Food and Drugs in the United States.  In 1962 the Kefauver-Harris Amendments to the Food, Drug and Cosmetics Act made it so that before a drug was marketed in the United States the FDA must first approve that the drug was safe. The Kefauver-Harris amendments also mandated that more stringent clinical trials must be performed before a drug is brought to the market. The Kefauver-Harris amendments were met with opposition from industry due to the requirement of lengthier clinical trial periods that would lessen the period of time in which the investor is able to see return on their money. In the pharmaceutical industry patents are typically granted for a 20-year period of time, and most patent applications are submitted during the early stages of the product development. According to Ariel Katz on average after a patent application is submitted it takes an additional 8 years before the FDA approves a drug for marketing.  As such this would leave a company with only 12 years to market the drug to see a return on their investments. After a sharp decline of new drugs entering the US market following the 1962 Kefauver-Harris amendments economist Sam Petlzman concluded that cost of loss of innovation was greater than the savings recognized by consumers no longer purchasing ineffective drugs. In 1984 the Hatch-Waxman Act or the Drug Price Competition and Patent Term Restoration Act of 1984 was passed by congress. The Hatch-Waxman Act was passed with the idea that giving brand manufacturers the ability to extend their patent by an additional 5 years would create greater incentives for innovation and private sector funding for investment. # ISO certification in India

The relationship that exists with industry funded biomedical research is that of which industry is the financier for academic institutions which in turn employ scientific investigators to conduct research. A fear that exists wherein a project is funded by industry is that firms might negate informing the public of negative effects to better promote their product. A list of studies shows that public fear of the conflicts of interest that exist when biomedical research is funded by industry can be considered valid after a 2003 publication of “Scope and Impact of Financial Conflicts of Interest in Biomedical Research” in The Journal of American Association of Medicine. This publication included 37 different studies that met specific criteria to determine whether or not an academic institution or scientific investigator funded by industry had engaged in behavior that could be deduced to be a conflict of interest in the field of biomedical research. Survey results from one study concluded that 43% of scientific investigators employed by a participating academic institution had received research related gifts and discretionary funds from industry sponsors. Another participating institution surveyed showed that 7.6% of investigators were financially tied to research sponsors, including paid speaking engagements (34%), consulting arrangements (33%), advisory board positions (32%) and equity (14%). A 1994 study concluded that 58% out of 210 life science companies indicated that investigators were required to withhold information pertaining to their research as to extend the life of the interested companies’ patents. Rules and regulations regarding conflict of interest disclosures are being studied by experts in the biomedical research field to eliminate conflicts of interest that could possibly affect the outcomes of biomedical research. # ISO certification in India

Transparency laws

Two laws which are both still in effect, one passed in 2006 and the other in 2010, were instrumental in defining funding reporting standards for biomedical research, and defining for the first time reporting regulations that were previously not required. The 2006 Federal Funding Accountability and Transparency Act mandates that all entities receiving over $25,000 in federal funds must report annual spending reports, including disclosure of executive salaries. The 2010 amendment to the act mandates that progress reports be submitted along with financial reporting. Data from the federal mandate is managed and made publicly available on usaspending.gov. Aside from the main source, usaspending.gov, other reporting mechanisms exist: Data specifically on biomedical research funding from federal sources is made publicly available by the National Health Expenditure Accounts (NHEA), data on health services research, approximately 0.1% of federal funding on biomedical research, is available through the Coalition of Health Services Research, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services, and the Veterans Health Administration. # ISO certification in India

Currently, there are not any funding reporting requirements for industry sponsored research, but there has been voluntary movement toward this goal. In 2014, major pharmaceutical stakeholders such as Roche and Johnson and Johnson have made financial information publicly available and Pharmaceutical Research and Manufacturers of America (PhRMA), the most prominent professional association for biomedical research companies, has recently begun to provide limited public funding reports. # ISO certification in India