Long before the latest global breast implant scare, American health officials were toying with the idea of building a registry that would track patients with implants. The registry would give a better idea of the number of complications over time, such as rupture or infection.
But to this day, none exists for the world’s largest health care market, which often serves as a global model for regulatory practice.
As early as 2000, U.S. health authorities raised concerns about the French breast implant maker at the heart of a scandal affecting hundreds of thousands of women worldwide. That was almost 10 years before the company came under scrutiny from European regulators.
The French government last week recommended that women in France who have PIP’s silicone gel-filled implants get them removed by their surgeons after the implants appeared to have an unusually high rupture rate. Other countries, including Britain and Brazil, said women should visit their surgeons for checks.
A critical question is why the FDA’s warning did not trigger greater scrutiny of PIP’s activities by regulators in France and elsewhere.
At the Henry Ford Hospital in Detroit, pharmacists are using old-fashioned paper spreadsheets to track their stock of drugs in short supply – a task that takes several hours each day.
Most of the hospital’s medicines – with usage estimated at $100 million a year – are tracked by automated systems that allow for quick reorders when the supply runs low. But these automated systems, designed to help the hospital avoid purchases and storage costs of unused pills and vials, do not work if it is uncertain when the next batch of drugs will come in.
U.S. lawmakers likely will change the criteria for advisers reviewing new medicines next year because of complaints that the rules meant to prevent conflicts of interest make it harder to find real experts. Congressional lawmakers may require the Food and Drug Administration to relax the rules that bar advisers from reviewing a drug if they have even indirect financial ties to related manufacturers, as part of an FDA funding bill.
Others say that the agency is not looking hard enough.
“There are lots of people out there who are smart and who don’t have conflicts of interest,” said Sid Wolfe of the consumer advocacy group Public Citizen.
Lawmakers are investigating three pharmacies in Maryland and North Carolina accused of passing critical drugs in short supply directly to wholesalers, who are likely to profit from the scarcity of life-saving medicines, rather than to the patients that need them.
According to details of the investigation made public on Wednesday, some wholesalers opened up their own phony pharmacies simply to get their hands on drugs in short supply and re-sell them to patients at possibly higher prices. In some cases, the pharmacy and wholesaler were headed by the same person, or by a husband and wife pair.