The FDA has an expansive mandate to gatekeep the entry of new pharmaceuticals into the U.S.

FDA Reform: Commonsense Fixes to the Drug Approval Process

The Taxpayers Protection Alliance released a new report ([link removed]) on the Food and Drug Administration (FDA) this week. The FDA has an expansive mandate to gatekeep the entry of new pharmaceuticals into the U.S. (and much of the world by extension). Drug developers spend more than $2 billion and roughly a decade to get a single product through the agency’s multi-phase approval process. Unless drug developers can show that their medications are safe and effective, agency officials will issue a product denial (in the form of a “complete response letter”) and the sponsor will have to remedy any testing, labeling, or design issues identified by the FDA. Dozens of companies each year manage to muster enough evidence to garner FDA approval. Public dialogue tends to focus on the promise and peril of approved products. For example, the approved coronavirus vaccines (e.g., Pfizer, Moderna,
Johnson & Johnson) were praised by a wide array of research scientists, physicians, and public health officials for significantly reducing COVID-19 deaths and hospitalizations. While some consumer advocacy groups and political figures expressed concerns about the safety of these vaccines, claims about significant adverse effects have been disproven. For all the ink spilled over the FDA’s approved products, there is preciously little discussion of drugs on the agency’s rejected list. There has been an uptick of complete response letters (CRL) in 2022, and agency approvals are at their lowest level since 2016. TPA’s new paper uses empirical research and “complete response” case studies to examine this newfound skepticism and explore the dynamics between agency officials and advisory committees (which issue non-binding recommendations). As will be shown, agency rejections are often arbitrary and regulators’ concerns could be remedied via post-approval changes and monitoring. Without
congressional oversight and reform, though, it is unlikely that the FDA will adjust its risk-aversion and embrace pioneering therapies.


No two drug evaluations look the same. Every New Drug Application (NDA) filed contains a wealth of unique clinical information and labyrinth of legalistic labeling language. Regulators spend thousands of hours going through these applications and soliciting the advice of advisory committee members who often have decades of research experience. Yet, all this experience and collaboration cannot make up for the risk aversion that continues to undermine the FDA and subsequently Americans’ health outcomes. The FDA should consider the following reforms to ensure an expedited, better-thought-out approvals process: Evaluate clinical trial data by the quality of empirics, not the country of origin. A sufficiently large, randomized study can usually yield valuable insights about the safety and efficacy of a medication. These insights do not stop at the U.S. border. Data primarily pertaining to one ethnic/racial group should be contextualized in labeling and not spurned wholesale. Embrace external
controls. Historical datasets may have shortcomings, but they also bring considerable value to the drug evaluation process. When possible, the FDA should split submitted data into control groups and ensure that proper comparisons are being made between the treatment group and comparator arms. Relegate manufacturing/logistics issues to post-approval monitoring. Since the start of the pandemic, virtually every industry has experienced manufacturing and distribution problems. These issues are often only fixed through trial and error and denying product approval only delays the process. Safety-related quality control issues do exist but these can often be resolved in a couple of months rather than a half-year.


A Supreme Case about the Internet


The Supreme Court heard arguments in Gonzalez v. Google this past week. This is a case that has the potential to upend the internet as we know it. In late 2015, a 23 year-old American named Nohemi Gonzalez tragically lost her life in a terrorist attack carried out by the Islamic State of Iraq and Syria (ISIS). Gonzalez’s family later alleged that YouTube’s recommendation algorithm led the attackers to ISIS recruitment videos. Therefore, they claim, Google – YouTube’s parent company – are partially responsible for Nohemi’s death. Google’s defense rests on a section of American law that has safeguarded the integrity of the internet for decades. The law, 47 U.S.C. § 230 (more commonly referred to as Section 230) holds that online platforms are not necessarily responsible for content published by users. For example, if a user posts harmful content on social media, that user – and that user alone – is responsible for the consequences of that post, not the social media company itself.

One of the original authors of Section 230, Sen. Ron Wyden (D-Ore.), describes his legislation as both “a sword and a shield” in online discourse. On one hand, it gives tech companies a shield from litigation for speech with which they did not create. This shield allows them to host a wide array of users’ speech online without fear of legal blowback. On the other, it gives these companies a sword to be able to remove potentially harmful posts as they see fit. Section 230 has struck an important balance in helping develop the internet as we know it. Section 230 enables websites to exercise their own speech, association, and property rights to offer competing versions of content. Some sites allow almost any kind of legal speech, while others only allow narrow categories, while many offer something in between. This allows for users to find the online communities that work best for them and their values. Because of this, lower courts have strictly stuck to the original intent of Section 230’s
authors. That is, Section 230 is meant to be broadly construed to protect online platforms from several types of claims, including those brought by the Gonzalez plaintiffs.

Inhibiting the ability of platforms to utilize algorithmic recommendations risks breaking what makes services like Google so valuable. Algorithms act like a magnet above a haystack, pulling out potential needles based on user feedback. Without them, much of the internet becomes a useless haystack.

Further, a ruling for the plaintiffs would potentially disrupt tech platforms’ ability to block illegal content in the future. If relative amplification becomes a legally damning action, then blocking any content would, by implication, be relatively amplifying everything else. It would become impossible to operate any kind of platform and Section 230 would effectively be repealed. What the plaintiffs are unintentionally asking for is for platforms to throw their hands up and let everything go. Unfortunately, that may open the door for more online activity like that which surrounded Nohemi Gonzalez’s tragic, untimely death. Platforms need the sword Section 230 provides as much as they need the shield. Section 230 opponents may try to eliminate one without the other, but the two are linked and the national online discourse will be worse should both be eradicated at the conclusion of this case.


BLOGS:


Tuesday: New Era of Frivolous Antitrust Hearings ([link removed])


Wednesday: FDA Reform: Commonsense Fixes to the Drug Approval Process ([link removed])


Thursday: The Cronyism Underlying Attacks On ‘Big Tech’ Must Be Brought to Light ([link removed])


Friday: Bill of the Month: Protect Farms from the SEC Act ([link removed])



MEDIA:


February 14, 2023: The Rutland Herald (Rutland, Vt.) ran TPA’s op-ed, “Stroud: Use latest data.”


February 17, 2023: WBFF Fox45 (Baltimore, Md.) quoted TPA in their story, “Baltimore City struggling to collect donations for squeegee kids.”


February 19, 2023: The Center Square ran TPA’s op-ed, “FCC Report Shows Wide Access to Broadband.”


February 20, 2023: WBFF Fox45 (Baltimore, Md.) interviewed me about Baltimore’s controversial conduit deal.


February 20, 2023: RealClear Markets ran TPA’s op-ed, “The Cronyism Underlying Attacks On 'Big Tech' Must Be Brought to Light.”


February 20, 2023: WBFF Fox45 (Baltimore, Md.) interviewed me about marijuana legalization in Maryland.


February 21, 2023: The Mountain News (Lake Arrowhead, Calif.) ran TPA’s op-ed, “Vermont state lawmakers ought to wait on latest data before moving forward with prohibition.”


February 21, 2023: WBFF Fox45 (Baltimore, Md.) quoted TPA in their story, “MD lawmaker pushes controversial vaccine bill while investing in several vaccine companies.”

February 22, 2023: The Washington Times (Washington, D.C.) ran TPA’s op-ed, “Medicare Advantage overbilling has cost taxpayers about $10 billion per year.”

February 23, 2023: WBFF Fox45 (Baltimore, Md.) interviewed me about the problems with the Maryland 529 college program.

February 23, 2023: I appeared on WBOB 600 AM (Jacksonville, Fla.) to talk about Big Tech and ESG.

Have a great weekend!

Best,
David Williams
President
Taxpayers Protection Alliance
1101 14th Street, NW
Suite 1120
Washington, D.C. xxxxxx
www.protectingtaxpayers.org ([link removed])

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