The controversy of Donald Trump’s remarks
on the FDA Regulatory Process

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Although the administration process at the FDA (America’s Food and Drug Administration) is generally thought of as being one of the speediest regulators on the planet, it is frequently criticized for being too slow and laboured.

Donald Trump says the FDA is too slow and burdensome

Only earlier this year, President Donald Trump gave a long diatribe to a Joint Congress session, explaining that in his opinion, the FDA’s regulation process was too long and drawn out, and certain drugs were far too expensive. While many would agree that certain drug prices are far too high, Trump’s aim to shorten the duration of the regulation process is the cause of some concern to the drugs industry.

In Trump’s opinion, the slow and burdensome FDA approval machine keeps too many medical advances from reaching those who need them in time. He went on to say that if FDA restraints were slashed, we would benefit from more miracles like the one that recently saved the life of Megan Crowley.  However, to put more perspective on the apparent slowness of the approval of the drug that cured Ms Crowley, Dr. David Kessler, the FDA’s commissioner between 1990 and 1997, said that the approval process, which happened over a nine month period, was not at all slow or burdensome.

Tinkering with generic pharma law could be costly

In addition to Dr. Kessler’s remarks, only last week a former team leader of the FDA, Thomas Marciniak, had his analysis published in the BMJ, also aimed at putting perspective on the drug approval process duration. It said that the actual date that a formal application is made to the FDA is often ignored, thus bringing about a misinterpretation of the real process time. The analysis concludes with a warning that slashing the regulatory process of generic pharma law by 80% as per Mr. Trump, could prove costly for both patents and healthcare budgets.

The fact of the matter is that some of the approval processing time is spent on drug companies being able to show that their drugs work in the way that they are supposed to. This means that they can get accepted by insurance companies for the benefit of more patients.

The FDA are still the world’s best drug regulatory body

When the FDA is compared to six of the world’s other drug regulatory bodies that have become faster at approving new drugs in recent years, they still come out on top according to the analysis undertaken by the CIRS (Centre for Innovation in Regulatory Science). While there is always room for improvement in terms of modifying generic pharma law, it must be carefully considered or we could be in for more Thalidomide type catastrophes.

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In today’s fast-growing, highly regulated generic pharmaceutical market, companies increasingly require specialized legal guidance as their products are developed, launched, and litigated. Wilson Sonsini Goodrich & Rosati’s attorneys address this need by providing expert counsel to companies in the global generics industry, offering sophisticated representation far beyond the scope of general corporate and securities counsel.

We have assembled a highly experienced team of experts from a cross-section of the firm’s key practice areas, including intellectual property, litigation, antitrust, FDA/regulatory, technology transactions, exports and FCPA, trade secret, and trademark and copyrights. Led by the former chief legal officer of Mylan Pharmaceuticals, one of the world’s leading generic and specialty pharmaceutical companies, our attorneys work closely with our generic pharmaceutical clients’ legal and scientific personnel and senior management to understand and meet their specific needs both in the U.S. and abroad.

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