Antiviral peptide tablets, a curative product that treats common (and sometimes deadly) flu-like symptoms, are scheduled to be launched in the U.S. as early as next month. Can the FDA’s supervision of antiviral study trials and monitoring procedures help avoid a U.S. shortage of the relief medication?
Small companies have sold the aerosolized vials of Vitamin C’s antiviral virus-fighting properties to America’s largest pharmaceutical companies and would-be purchasers, helping supplement other sources of flu medicine. But like a sudden, mysterious surge in prescription opioids, authorities are under tremendous pressure to make sure that one of their most crucial medications is available to any patient who could benefit from it.
U.S. regulators have agreed to better monitor multiple clinical trials because they have previously failed to spot and control shortage risks in human trials before actual shortages occur. But it is unclear whether this agreement will keep a bedlam of viruses and influenza in check. The virus-fighting advantages of the new drug – their fast-acting venom, their mild ability to carry out high doses – may give little advantage to patients who need the drug after they have licked the painful and sometimes fatal symptoms of the flu.
“This is a dangerous problem,” said Pieter Chung, a professor of medicine at McMaster University. “There are other [antiviral] products that are already available, there are antiflu products available, and the antiviral drugs already have an approved use. This is a new, emerging, new drug.”
The Food and Drug Administration has approved a number of antiviral peptide drugs, including the anti-parasitic drug Merdocid, which has cost $80 million in developing from test tests to its planned launch in September. The disease is spread by certain kinds of flu viruses that are causing a high number of the recent outbreak in dozens of countries.
As millions around the world have sought treatment, some hospitals and healthcare workers have been overrun by sales calls, pharmacy receipts and the nightmare of pharmacies shipping the vials so fast that new orders come in daily. Some pharmaceutical companies (including Merck and GlaxoSmithKline) have said they expect to run out of the pills as early as October.
“The company needs access to these drugs, because it’s not unusual for the drug to be tested and approved after it takes over a decade to bring it to market,” said Jonathan Wood, a corporate development lawyer for the health law firm Mayer Brown. “It doesn’t mean these drugs are necessarily safe and effective in this situation. That’s for the FDA to rule on.”
Last week, the FDA said that it had designated some of the clinical studies as “unduly burdensome,” to help pharmaceutical companies sidestep a review procedure for doing such studies. The agency said that more studies of these drugs would also be exempted from a review, and that there was no need for manufacturers to submit notifications that would indicate they had met every single development hurdle.
“It seems the agency was never consistent with that very good safety and efficacy practice of requiring prior approval,” said Anick Poirier, a Washington-based healthcare policy analyst at the non-profit Center for Global Development. “If something works, why would it need to be approved beforehand? This is exactly the sort of thing that is being debated in the debate around value-based healthcare: Should we be maximizing benefits first, to prevent the need for expensive interventions and to limit the need for regulatory reviews? Or would it still be good to have a safety and efficacy analysis done to improve things if there is a problem?”
The drug also differs from other flu treatments in that it is very long acting: It carries the unique viral strain of flu that causes symptoms, and it prevents the viral infection. But at 2,000 hours after a dose, the medicine is said to go dormant. If it is not activated within a certain amount of time, symptoms may return, even after they have eased. One possibility is that people who use the drug may not be able to remember when to take a dose, or may be unwilling to take it daily, because the constant, often painful, pain over time would perhaps undermine its effectiveness.
“It’s a very well-known possibility that there are resistance mutations going to arrive,” said Michael Stavropoulos, a clinical pharmacologist at the Institute for Regenerative Medicine, whose patients are currently without flu medication.
The Food and Drug Administration declined to comment on whether the agency had the expertise or legal ability to regulate or approve new