Former FDA Commissioner Proposes Drug Reform

Drug recall lawyers at Pintas & Mullins Law Firm report that the former FDA commissioner, Dr. Andrew von Eschenbach, and University of Chicago’s Dr. Tomas Philipson recently proposed a new system that would eliminate late-stage studies for new medications. They argue that shortening the approval time will eventually help lift the U.S. economy, while critics say this is just another example of exploiting patients for profits.

Philipson and von Eschenbach are proposing this new system because they believe it will help stimulate our struggling economy and reinstate the U.S. as a leader in medical innovation. They believe that, by restricting the FDA’s clinical trial requirements, the biopharmaceutical industry will enjoy greater success, therefore bringing increased revenue to our economy.

Specifically, they are proposing to eliminate Phase Three clinical trials, which they deem excessively expensive, time-consuming, and ultimately unnecessary. Medical science changes at rapid, often overwhelming speeds, and the FDA has been criticized for not being able to keep pace. With current regulations, it takes about 12 years and more than a billion dollars to develop one new drug and have it FDA-approved.

Phase Three trials are designed to focus almost exclusively on the drug’s effectiveness, account for about 25% of industry research and development costs, and require about three years to complete. Philipson and von Eschenbach are arguing that this long process shortens patent life, delays sales, and may be causing more harm than good.

They elaborate on this point by stating that Phase Three trials often fail to recognize the potential many medications have for smaller patient groups. Second, they argue that improved information technologies and monitoring capabilities will enable the government to effectively survey drug safety post-market. Lastly, they are claiming that eliminating Phase Three trials will most likely not induce further patient harm, as evidence supporting drug safety is proven in previous trials.

Although these arguments provide basis and evidence that eliminating Phase Three trials could be beneficial to the economy, in no place do they mention the critical importance of testing the efficacy of new drugs before they are publically released. Patients must be made aware, before ever consuming a medication, of the full list of risks and benefits. This is a basic consumer right. And it is only with a full risk/benefit report that the FDA can adequately judge whether or not a drug is safe for public consumption.

In the proposal, new drugs would be released onto the market only after promising early-stage research is proven, and post-marketing studies will be universally required. In this way, patients would be the ultimate judge on the quality of the medications, or, to look at it another way, patients would become the guinea pigs.

In 2012, the President’s Council of Advisors on Science and Technology released a report stating that there was widespread agreement that the current clinical trials system is inefficient. It is clear that something should be done about the current, out-dated regulations surrounding drug approvals, however, completely eliminating Phase Three trials is not the way to do it.

This proposal would undoubtedly lead to more drug recalls, more product liability costs, and more patients prematurely dying and sustaining life-altering, permanent injuries. In turn, this would lead to decreased public trust in the biopharmaceutical industry, which is already subject to immense suspicion, criticism, and litigation. Of course, it is only through growth, not tax hikes and budget cuts, that the US will be able to reduce its immense deficit. The biopharmaceutical industry currently makes up about 2% of the US economy, and does indeed have influence, but alternative options must be considered before putting patient safety in jeopardy.

Drug recall lawyers at Pintas & Mullins Law Firm have earned an esteemed reputation for protecting consumers against dangerous prescription drugs. As many as 200,000 Americans die each year from adverse reactions and side effects of pharmaceuticals – a number that should not increase in effort to increase industry profits. If you or someone you love was seriously injured by prescriptions medications, you have important rights, and may be entitled to compensation.