Tag: FDA

News & Research, Treatment

Clear and Direct Drug Info on the Way?

Kerrie Smyres

New FDA rules require that the information sheets accompanying prescription drugs be clear and direct — at least more so than they currently are.

The sheets, which the industry refers to as labels, will highlight vital information that docs need to know to prescribe a drug safely, including warnings, recent changes to the label, how to use the drug and what the dose the drug follows. There will also be a section specifying what doctors should tell patients about the drug.

Because the labels will be less obtuse than they currently are, FDA officials expect that drug advertising will change dramatically. Presumably if you can’t be obscure in one place, it isn’t allowed in the other either.

The new information will be integrated into the electronic label that drug companies are required to submit to the FDA. The expectation is that this will make detailed drug information more accessible to the public.

This could be a big step in the right direction.

Society, Treatment

Good Old Days of Meds Not So Good

Kerrie Smyres

Longing for the days of safe, reliable medications? A drug discovery researcher says those days never existed. The health risks of drugs like aspirin, penicillin and acetaminophen, he claims, are great enough that many older meds wouldn’t have received FDA approval. Some wouldn’t have even made it to FDA review.

He concludes with, “What are we to make of all this? It’s possible to be both glad and worried. We can be relieved that we’ve learned so much more about pharmacology, ensuring that the drugs that manage to gain approval today are the safer than ever. Or we can think about how people seem to use aspirin and the other legacy drugs anyway, safety problems and all, and wonder how many more useful medicines we’re losing by insisting on a higher bar.”

I lament how how often drugs are approved on on the market before serious health risks are found (or revealed). But before any product is marketed a company (and the FDA in this case) considers the known risks and benefits. If a drug or medical procedure potentially helps significantly more people than it might harm, the benefits may outweigh the costs. It’s the same approach that insurance companies use.

If someone accepts that’s medications can’t be totally harmless and chooses to take a drug anyway, shouldn’t he or she know all of the risks beforehand? Truly it wouldn’t be difficult for drug companies to hide information about a drug’s harmful effects in plain sight. Isn’t that what’s been done with aspirin?

via Kevin, MD and Medpundit

Society

Day One of DTC Drug Ad Meeting

Kerrie Smyres

Researchers Urge FDA To Require Prescription Drug Risks To Be Placed Prominently in Ads

Article highlights:

  • Information about drug risks must be presented in a more consumer-friendly format and displayed more prominently in ads (Ruth Day, Assistant Professor at Duke University)
  • After reading or viewing a drug ad, “80% of people can recall what a drug’s benefits are; 20% can recall what the side effects are.” (Ruth Day)
  • FDA should have a mandatory review of ads before they are released (AstraZeneca, written testimony)
  • FDA shouldn’t micromanage drug ads (John Kamp, Coalition for Healthcare Communication
  • It’s critical, from a public health standpoint, that the advertisements are truthful and balanced (Janet Woodcock, FDA Deputy Commissioner for Operations)
Meds & Supplements

FDA Requires Electronic Drug Labels

Kerrie Smyres

FDA now requires drug companies to submit electronically prescription drug information to the agency. The idea is to give health care providers and the public easier access to the information found in inserts included with prescription meds. In practice, this will likely mean that the hard-to-read package inserts will be exactly the same but searchable online.

Insert information will be available via the National Library of Medicine‘s DailyMed. To be confused by government jargon and too much detail, see FDA’s press release. (FYI, FDA refers to the information as labels.)

(Via Kaiser Network‘s Daily Health Policy Report; FDA To Announce New Requirement That Drug Makers Submit Digital Labels for Medications)

Meds & Supplements, Society

FDA Forum on DTC Drug Ads

Kerrie Smyres

A two-day FDA public forum on direct-to-consumer drug advertising began today. Spurred on by public and political opposition to current DTC ads, the FDA will use information gathered during the forum to issue advertising guidelines.

In an attempt to stave off regulation, industry trade group Pharmaceutical Research and Manufacturers of America (aka PhRMA) issued its own guidelines earlier this year. Those guidelines don’t take effect until January 2006. Drug companies spent $2.94 billion on ads from January through August 2005. 2004 spending for the same period was $2.88 billion.

For more details about the controversy leading up to this week’s meetings, read ‘Ask Your Doctor’ Ads in FDA Crosshairs. CNN describes dug companies’ reimaging attempts in Drug Industry Could Use a Face Lift.