“Competition should always drive cost – never – never quality,” the pipes writes.
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America’s general drug market is one of the biggest successes of our health policy. Today, 91% of all recipes In the US they are filled with generic. This dominance saves patients and taxpayers hundreds of billions of dollars each year – and also leads to innovation. Pharmacists know their monopoly on a new treatment will be temporary – typically enjoying only 12-14 years Effective market exclusivity – which urges them to continue to invent rather than violate the old medicinal products.
This success is based on a simple but powerful principle: generics can compete with price, but never sacrifice quality or security. Patients and doctors trust generics because they should be clinically equivalent For their counterparts with surnames, the treatment of active ingredients, dosage, pathway, therapeutic effect and safety. THE Act of Hatch-Waxman of 1984 It guarantees this principle by striking a balance that has made the American general market the strongest in the world – and the more accessible.
Now, the FDA is jeopardizing trust.
Has issued the FDA New plan rules on aluminum infection in certain injectable drugs. These drugs are structural elements of intravenous diet given to premature babies that cannot yet feed. For these fragile newborns, they are very aluminum Not a small issue– It can cut bone growth and reduce brain growth.
For decades, the FDA has insisted that aluminum exposure would be kept in the absolute minimum. But new guidance relaxes these limits. It effectively prohibits generous allowances for each ingredient, even if the combined set pushes right to the danger zone. Guidance also allows the so-called “skinny labels”-the instructions for the dispute that they assume that hospitals will only use products as written. But the FDA knows that it has little control over how medicines are really used in real world hospital arrangements. The result is that some manufacturers will now be able to sell products with much more aluminum than the safest versions already on the market.
This is a problem for two reasons.
First, premature infants often need more than a handful of these nutrients. When mixed together, FDA mathematics simply do not add – the overall exposure can easily exceed the security limit. And worse, neither doctors nor parents will know exactly how much aluminum is taking a premature baby from these products – information that is critical to making safe treatment decisions.
Secondly, it punishes companies that invest in cleaner, safer production methods. A branded manufacturer has shown that it can reduce aluminum by almost 98%. Instead of rewarding this innovation, the new FDA approach leans the field to the corner girls.
The organization justifies this as a way of preventing shortages. But this is a red herring. The body his own reference He has shown that the real causes of shortcomings are the minutes of profit margins and bad production practices. Reduction of security standards will not correct these problems – but will drive responsible producers from the market and endanger vulnerable infants.
The bets exceed premature babies. If the FDA is willing to fall protection down here, what should it stop doing the same? The Hatch-Waxman genius was its bright line: the generic had to match the original medicine to safety and efficacy. The moment regulators blur this line, the public’s confidence in the whole system begins to unfold. Doctors are reluctant to prescribe, patients resist change and costs increase for everyone.
More than 7,000 American babies born prematurely each week are worth incompatible protection. Instead, the FDA guidance plan sends the opposite message: that standards can bend and security is negotiable.
Competition should always drive the costs down – never quality. The FDA should withdraw this incorrect guidance before it hurts vulnerable infants and undermines the confidence that our general system makes.
