The prospect of a major change to the regulatory agency comes as drug makers are under fire for high prices, including Marathon Pharmaceuticals LLC, which said "stop" the launch of its drug Duchenne muscular dystrophy after American lawmakers questioned her $ 89,000 a year award.
US President Donald Trump's wish to overturn government regulations at least 75 percent raises concern for some pharmaceutical executives that a less robust Food and Drug Administration would make insurance coverage more difficult for new Expensive drugs.
The biotechnology industry group Biotechnology Innovation Organization said that during the high-level discussions with Trump's advisors lobbyists urged the administration not to appoint a new commissioner of the Food and Drug Administration who would act rashly to accelerate the approval of new medicines.
This position underscores the unique position of the pharmaceutical industry in regulating its products. While most sectors receive less oversight, drug manufacturers say a strong review process is essential to convince physicians and insurers that new medicine is expensive. Otherwise, the time and money needed to get a new drug on the market - up to $ 2.6 billion - would be lost if insurers were not willing to pay for the product.
“People often argue that the FDA is too restrictive,” said Roger Perlmutter, head of research and development at Merck & Co Inc. “We have the sense that the balance is pretty right … you have to have a well-characterized risk/benefit profile.”
"It's great that the administration is seeking deregulation to ensure that the private sector can be more competitive," said John Maraganore, managing director at Alnylam Pharmaceuticals Inc. and co-chair of BIO's regulatory committee. "But payers are looking for evidence of value."
“Any change at the FDA that allows drugs to be tried out on patients without clinical evidence is a damaging approach,” said Jeremy Levin, chief executive officer at Ovid Therapeutics Inc., which is developing drugs for rare diseases.
“It is one thing to get a drug approved, but you have got to get reimbursed,” said Paul Perreault, CEO at biotech company CSL Ltd, adding that won’t happen unless payers see proof that a new drug is better than what is already available.
To be sure, some pharmaceutical executives have been vocal about the need for deregulation. Reducing regulation “will help with drug prices, because it will induce more competition,” Pfizer Inc CEO Ian Read said on a recent conference call. Health insurers push back expensive drugs. Cholesterol sales of new drugs Amgen Inc. and Regeneron Pharmaceuticals Inc. have blocked that insurers limit coverage until they see test results designed to prove that drugs significantly reduce the risk of heart attack and heart disease. Other cardiovascular attacks.
After senior executives from Merck, Johnson & Johnson and others met at the White House last month with Trump, which pledged to "rationalize" the FDA, the pharmaceutical group Research and Manufacturers of America Said the meeting found common ground, and the removal of obsolete regulations. The trade group refused to comment on the changes to the FDA. The prospect of a reversal to the FDA is being welcomed by a new class of investors with the ambition to disrupt the current model of drug development, in which the major pharmaceutical players often buy or license drugs early in the stage, and to reap the greatest rewards if they succeed.
He supports the notion that some prescription medications could reach the market, possibly at discounted prices, once testing shows they are safe. If such controlled usage indicates that they are also effective, prices could then be raised.
“We want to make healthcare itself more efficient,” he said. “Let the marketplace decide how valuable a drug is.”
The candidates, according to sources close to the administration, include Scott Gottlieb, a former member of the FDA, and Jim O'Neill, a colleague of Trump's supportive Peter Thiel, Get to the market once if there is little evidence that they are working. A recent poll conducted by Mizuho Securities found that 72% of respondents said that Gottlieb should be Trump's choice to lead the FDA. "There is no movement background movement for change," said lawyer Jim Shehan, head of Lowenstein Sandler's FDA regulation. "The industry
