Allergy & Asthma Network Mothers of Asthmatics (AANMA)

Lawmakers Agree to Take a Look at Challenging FDA Proposal on Allergy, Asthma Drugs

Published May - 15 - 2012 Print This Post

By Melissa Attias, CQ Today Online News

Lawmakers from both parties on Thursday agreed to help allergy and asthma advocates in their effort to block a Food and Drug Administration proposal that could make some prescription medications available over the counter.

Under the proposal, which FDA announced it was considering in February, some drugs that currently require a prescription
could be bought without one as long as certain conditions are met. For example, patients could be required to consult with a pharmacist or could use a kiosk in a pharmacy to help self-diagnose a condition. Some medications also could require an initial prescription but then be made available over the counter for refills.

The idea is that increasing access to medication could help encourage more people to seek treatment for common conditions and stay on their medications. FDA also notes that it could give doctors more time to spend with more seriously ill patients instead of giving their attention to refill-related tasks.

But members of the Allergy and Asthma Network Mothers of Asthmatics are concerned the proposal would increase risks and costs for patients with allergies and asthma. They say the proposal lacks evidence and conflicts with national guidelines, and they question what health insurance premiums would cover if the proposal goes through.

“The paradigm reclassifies patients as customers,” Nancy Sander, the group’s founder and president, said at a briefing. “It sends us to pharmacies and pharmacists and kiosks for paint-by-number diagnostics.”

A handful of lawmakers spoke at the briefing, including three of the four co-chairmen of the Congressional Allergy and Asthma Caucus: Republicans Joe L. Barton of Texas and Bill Cassidy of Louisiana and New York Democrat Eliot L. Engel.

Sander asked Engel whether he would help the group ensure that the proposal is not implemented and he agreed, directing her to a health aide.

“Talk to her and we will make sure,” Engel said. “I will make that a crusade.”

Sander also asked Florida Republican Cliff Stearns what advocates could do to block the FDA proposal from taking hold. Stearns said if the group felt strongly about the issue, it could draft legislation and circulate it to stakeholders to find appropriate language, adding that he would be glad to help.

“It’s not without the realm of possibility we could have a bill to stop the FDA from doing this,” Stearns said.

Sander also told advocates that Cassidy had agreed to look into the issue.

FDA held a public hearing on the idea in March with mixed reviews. Physicians questioned whether patients are equipped to diagnose and monitor their own conditions. Pharmacists seemed open to advising more patients, but issues such as pay and liability will be key to their support.

FDA is reviewing public comments on the initiative and will determine its next steps once that is completed. The comment period ended May 7.

Rebecca Adams contributed to this story.

Source: CQ Today Online News; May 10, 2012 – 4:53 p.m.

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