Monday, May 19, 2014

Health Affairs:FDA and Primary Care

Health Affairs briefing at the National Press Club in Washington, DC,

The clinical and economic virtues of provider consolidation have long been recognized by policy experts, but in recent years, research has shown that large provider organizations may use market power to obtain relatively high prices from payers without necessarily delivering superior quality. On May 19, Health Affairs will release a package of "Web First" papers examining questions regarding provider consolidation.

Follow live Tweets from the briefing at @HA_Events, and join in the conversation with #HA_ProviderConsolidation.  We invite you to a Health Affairs briefing at the National Press Club in Washington, DC, where the authors will present their findings and engage in a discussion with a panel of expert responders and the audience. The papers and the briefing are supported by a generous grant from The Commonwealth Fund.
WHEN:
Monday, May 19, 2014
9:00 a.m. - 10:30 a.m.
WHERE:
National Press Club
529 14th Street NW
Washington, DC
13th Floor (Metro Center)



Physicians and Pharma have long complained about the length of time for new drug approval by the FDA for clinical use.  Pharma is required to perform Clinical Trials, I, II, and III to test for toxicity, effectiveness, and possible side-effects. Various amounts are quoted for the process of approval.  These add significantly to the costs of biochemical and pharmacological production. Health Affairs and the Robert Wood Johnson Foundation describes a new expedited drug development pathway designed to speed up the Food and Drug Administration's (FDA's) premarketing approval process for drugs and devices that treat serious or life-threatening conditions. Created under a 2012 law, the Food and Drug Administration Safety and Innovation Act (FDASIA), a drug may be designated a "breakthrough therapy" if it shows far more promise over comparable treatments already on the market. At that point, the FDA will initiate a special rapid approval process. The pharmaceutical industry has responded positively to this law, and as of last month the FDA has received 178 requests for this designation. The law, whose full impact will not be known for several years, carries significant implications for approaches to clinical development, patient access to new drugs, and the drug regulations process itself.


Josh Seidman discusses the implications of the social media response to the release of information on Medicare payment to specific physicians. This is the first time physician reimbursement amounts have been released to the public.


ABOUT HEALTH AFFAIRS:
Health Affairs, published by Project HOPE, is the leading journal of health policy. The peer-reviewed journal appears each month in print, with additional Web First papers published weekly at www.healthaffairs.org.

Laudable but excessive prevention and public health initiatives have been added to the work load of primary physicians who are already hard-pressed to comply with a multitude of bureaucratic requirements. These additonal requirements may have a negative effect on primary care duties.

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