Attorney David L. Goldman from the Sarasota personal injury and civil trial law firm of Shapiro Goldman Babboni & Walsh has informed clients of a potential reduction in prescription drug safety resulting from upcoming policy changes.
SARASOTA, Fla. – Dec. 20, 2016 – PRLog — Mr Goldman stated, “Safety standards of the Food and Drug Administration (FDA) are likely to be weakened by both Presidents Obama and Trump. The ’21st Century Cures Act,’ a bill which President Obama will soon sign into law, provides much needed funding for health research. It also provides monies for dealing with our national opioid crisis, as more Americans now die from drug overdoses than from car crashes or guns.”
Attorney Goldman continued with, “However, the new law does undermine the FDA’s regulatory authority by eliminating the need to perform clinical trials with control groups for companies seeking approval of a new indication of an existing drug or for marketing efforts. Instead, drug companies would only have to provide data that are observations and not experiments with placebo controls. This can be easily manipulated at the cost of consumer safety. This is equivalent to a fox guarding the henhouse, and it is hard to see how this will not be exploited to the detriment of consumer safety.”
Attorney Goldman cites an article by Journalist Julia Belluz, which stated, “The [21st Century] Cures Act would also allow the FDA medical reviewers to use ‘summary-level reviews’ written by drug companies when making decisions about new indication approvals, instead of raw data. Now, this provision wouldn’t require the FDA to rely on these summaries. But it gives FDA officials permission to not look at the raw data. While this may speed up the approval process, the reviews may be biased in favor of the drugs (remember — they are created by the industry trying to get their products passed by the FDA). And critics worry that, because the FDA is starved for resources, officials will wind up using these summaries more often than not.”
Mr. Goldman continued with, “Yet these new concerns about drug safety may just be the tip of the iceberg. President-Elect Donald Trump is considering appointing James O’Neill, a Silicon Valley investor and associate of billionaire Peter Thiel, as FDA head. O’Neill has no medical background, but very strong views about eliminating all medical regulation. In other words, the FDA might no longer require clinical trials with placebo controls or even summary-level reviews if O’Neill heads the FDA. O’Neill may just allow drug companies to put any drug on the market without regard to whether they are safe or effective. It is also reported that President-Elect Trump is considering Dr. Scott Gottlieb, a venture partner at New Enterprise Associates and former deputy commissioner for medical and scientific affairs at the FDA, to run the agency. Although Gottlieb is considered to be a conservative who will likely continue to weaken the FDA’s regulatory authority, he is considered by most to be a far less risky choice to head the FDA.”
About Attorney David L. Goldman:
Mr. Goldman is a member of the American Association of Justice, The Association of Trial Lawyers of America, and the Southern Trial Lawyers Association. Mr. Goldman is an Eagle Member of the Florida Justice Association and The Academy of Florida Trial Lawyers, and received the prestigious Legislative Leadership Award by that organization in 1997.
David Goldman has a long-standing commitment to the community and has served as a board member of many civic organizations. He has worked extensively with the Gulf Coast Latin Chamber of Commerce, the Sarasota African-American Chamber of Commerce, Second Chance Last Opportunity and the Westcoast Center for Human Development. He has also served on the Board of Directors of the Sarasota-Manatee Jewish Community Center and has been a director and member of the Endowment Fund of his local synagogue.
Attorney David L. Goldman
Shapiro Goldman Babboni & Walsh
308 Cocoanut Ave., Sarasota, FL 34236