FDA Has Power to Make Prescription Drugs Go Over the Counter

June 13, 2001 (Washington) — On the off chance that the FDA says so, drug companies will have to make prescription drugs available to customers over the counter.

Janet Woodcock, MD, executive of the FDA’s Center for Medicate Assessment and Inquire about, told a House panel that the agency has the control to compel the producers of three popular, nonsedating hypersensitivity drugs to offer the drugs specifically to the open.

“We felt we had the authority to do this, that we have legal recourse,” Woodcock said to reporters amid a break in the hearing. It was the first such public affirmation from an agency official.

Without indicating fair what the FDA would do if the manufacturers don’t comply, Woodcock wouldn’t rule out the thought of “misbranding” the drugs in case they proceed to carry a prescription prerequisite. That, in effect, would constrain them over the counter or off the advertise.

The issue became a open contention last month when an FDA admonitory panel recommended that Schering-Plough’s Claritin, Pfizer’s Zyrtec, and Aventis’ Allegra be sold without a prescription. That taken after a request filed by Wellpoint/Blue Cross, a huge wellbeing arrange that had ended up greatly concerned about escalating sedate costs. If the FDA goes at the side of the request, it would be an unprecedented move. In the past, drug manufacturers have always made the starting request to go over the counter, not an exterior party.

It’s still not clear when the FDA might act on the questionable ask, but the pharmaceutical industry has all but promised to take the matter to court to try and block it. “Constrained switches are being proposed by guarantees seeking to shift costs to patients. These third parties need the essential data to determine whether a switch is suitable. … Switches based on deficiently data may put the public at chance,” Gregory Glover, MD, JD, of the Pharmaceutical Producers of America, or PhRMA, said in testimony prepared for the House Vitality and Commerce Health Subcommittee.

“In all the other cases except for the one we’re talking about here nowadays, the antihistamines, the manufacturers are strong of such a switch,” said Woodcock. Eventually, she said, the drugs would need to meet exacting criteria in case the FDA moves them to over-the-counter status.

“On the off chance that the customer cannot fittingly select for themselves, diagnose for their condition, at that point [over the counter] is off the table,” said Woodcock.

Another issue discussed by the officials is whether a key pharmaceutical patent law known as the Waxman-Hatch Act would have to be amended. The goal of the 1984 measure was to suit the needs of companies that make not only the unused drugs, but companies that make the generics, as well. However, Rep. Sharrod Brown (D-Ohio) says the brand-name companies have found ways of circumventing patent limits on branded drugs. The net effect is to stall the entry of cheaper generics into the marketplace.

“Brand-name companies file last-minute patents on their drugs, because they know that by suing a bland for obvious infringement, they can consequently delay FDA approval by 30 months,” Brown told the panel. “And brand-name companies cut deals with generics to keep them off the showcase. … We ought to not all have to pay to diminish their time in court,” Brown proceeded.

“The FDA’s truly been struggling with these issues with all the court decisions,” says Woodcock.

Brown focuses out that drug costs rose more than 300% within the last 20 years, more than three times the rate of swelling.

But PhRMA’s Glover responds that in spite of the industry’s arguments, generics have not faced obvious issues except in a modest bunch of cases. “[W]e emphatically oppose such changes that would, we accept, unfairly skew the law in favor of nonexclusive producers and obstruct the ability of the research-based industry to realize … the accelerating biomedical advances for patients in all of the world,” he says.

Ironically, even in spite of the fact that drugs applying for bland status have as of now been on the market beneath a brand name, their average approval time is 18 months vs. just 12 months for new drugs. Among the reasons, says Woodcock, are that generic companies don’t have the assets that their brand-name competitors do to put into the approval process. In expansion, the FDA doesn’t receive “client fees” to assist sedate surveys from nonexclusive firms as it does for brand-name items.


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