FDA Considers Looser Prescription Rules

By Mary Silver
Epoch Times Staff
Created: May 1, 2012 Last Updated: May 4, 2012
Related articles: United States » National News
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The new FDA regulations would make it possible for certain types of medications to be bought over the counter, bringing their cost down. (Joe Raedle/Getty Images)

The new FDA regulations would make it possible for certain types of medications to be bought over the counter, bringing their cost down. (Joe Raedle/Getty Images)

The FDA is proposing new rules to allow patients to buy certain kinds of drugs without prescriptions. Adding a new class of over-the-counter drugs is meant to make it easier and more affordable for sick people to get medicine.

For safety, the new class of drugs should still be dispensed through pharmacies, where patients would have the benefit of expert advice, according to testimony at an FDA hearing last month.

Beverly Schaefer, registered pharmacist and owner of Katterman’s Sand Point Pharmacy in Seattle, Wash., said pharmacists are clinically trained medication experts, and making it easier for people to get the medicine they need would lead to better health outcomes.

Schaefer spoke for the National Community Pharmacists Association (NCPA) at the FDA hearing. In her opinion, overburdened emergency rooms, inconvenient hours at doctors’ offices, and long waits for appointments with doctors, all make it hard for people to manage acute conditions and hard for them to comply with prescribed medication regimens.

The drugs in the proposed new class include asthma rescue inhalers, antivirals, antihistamine eye drops for allergy relief, and steroid nose sprays to reduce inflammation in sinuses. Epinephrine pens (also known as EpiPens) treat life-threatening anaphylactic shock for those with severe allergies, such as to peanuts or bee stings. The pens would no longer need a prescription under the proposed rules.

“NCPA members fully support a nonprescription class of drugs with conditions of safe use and believe such a class will have a positive impact in enhancing public health, if used appropriately with pharmacist intervention,” said Schaefer in a statement. “Benefits of the class include increased access to health care, improved utilization of health care resources, increased adherence to chronic use medications, decreased overall health care costs, and improved collaboration between members of the health care team.”

Sandra Adamson Fryhofer, M.D., chair-elect of the American Medical Association’s Council on Science and Public Health, testified for the AMA. She said she was concerned about people with chronic illnesses having less communication with doctors if the new rules take effect.

“While the increased availability of certain prescription-based antidotes, such as EpiPens, appear to have few if any safety concerns, the FDA has not offered evidence that patients with hypertension, hyperlipidemia, asthma, or migraine headaches can self-diagnose and manage these serious chronic medical conditions safely on their own,” said Fryhofer in a statement.

The proposed rules would not reduce the load on emergency rooms, or do much to improve people’s health, in her opinion. “The range of chronic medical conditions or diseases currently managed by prescription drug products that might improve patient outcomes if diagnosed and treated under this proposal is probably limited. An expansion of OTC drug types is also not likely to reduce the burden on emergency rooms,” wrote Fryhofer.

If the rules take effect, it would shift some Medicare costs from the government to the patient. Medicare has a prescription drug benefit. Over-the-counter drugs are not covered, so a Medicare beneficiary would have to pay out-of-pocket for asthma rescue inhalers, EpiPens, and other drugs in the new class.

The FDA is requesting public comment on the matter until May 7.


  • Michael678

    Public misinformed about seal of approval from US drug agency
    Efthimios Parasidis
    Assistant Professor of Law at Ohio State University

    Between 2005 and 2011, nearly half of all new drug formulations in
    the US were approved without companies having to demonstrate a tangible
    benefit, such as relieving disease symptoms, extending life, or
    improving someone’s ability to go about normal activities.

    What patients really want is evidence that the drug they are taking
    will actually improve their condition. But the FDA, the American drug
    regulator, doesn’t routinely consider this for new molecular entities (NMEs) – drugs that have innovative chemical structures that have never been marketed before.

    The findings come in a new paper
    by Nicholas Downing of Yale University and colleagues, part of a series
    on the drug approval process published in the Journal of the American
    Medical Association (JAMA), that found there was wide variation in the
    quality of evidence considered by the FDA. They also found that nearly
    two out of five drugs approved by the FDA was brought to market after a
    single pivotal trial.

    A second paper
    in the series documented the lack of data required by the FDA when it
    considers approvals for medical devices – the study found that only 14%
    of high-risk medical devices, such as pacemakers and other
    cardiovascular implants, were assessed in one randomised control trial.

    Both studies strongly suggest that the FDA is approving products that
    may not have accurate risk-benefit profiles, which could place patients
    at risk.

    Sleeping watchdog?

    While patients and physicians rely on the FDA to serve as an
    appropriate gatekeeper and watchdog, opinion polls reveal the public is
    misinformed as to what the FDA seal of approval actually means. For
    example, a national randomised trial conducted in 2011 found that
    39% of US adults believe the FDA approves only “extremely effective”
    drugs, and 25% believe the agency only approves drugs that do not have
    serious side effects.

    In addition to debunking these commonly held myths, the Downing paper
    is part of a long line of comprehensive studies that have highlighted the limitations of the FDA’s review process for new drugs before they hit the market.

    Because pre-market studies are limited in duration and scope, they
    often fail to capture later adverse events, or adverse effects that only
    happen to a small percentage or sub-population of patients. At the same
    time, pre-market studies often include research subjects who are not
    representative of “real-world” patients. For example, studies typically
    don’t include patients who are taking multiple medications.

    The findings also affirm what commentators and FDA Commissioners have
    long argued – that the FDA should take a more proactive role in
    reviewing drugs and medical devices once they hit the market, to make
    sure adverse events are logged and considered.

    No one wants an approval process that drags
    on for a long time. So when it comes to catching later problems, the
    only meaningful alternative is to require that drug and medical device
    manufacturers actively review post-market data and report their findings
    to the FDA – something that needs manufacturers to actively engage

    Inside the FDA

    Since the 1960s, the total number of drugs approved has been falling
    on average, according to data collated by The Conversation. This is
    happening at the same time as the cost of research and development is
    going up. In another study
    in the JAMA series, six FDA scientists looked at the reasons why
    approvals for drugs might be delayed or denied. According to the paper,
    between 2000 and 2012 a half of NMEs were approved when first submitted
    to the agency and nearly 75% were ultimately approved. Some of the
    reasons why new compounds failed to earn FDA approval included
    inadequate performance and problems with doses.

    It’s a hugely important paper because information from the FDA on why drugs aren’t approved is limited, due to data sharing issues (despite recommendations from its own transparency taskforce).

    The study is sure to provide meaningful guidance to pharmaceutical
    companies as they contemplate, prepare or conduct pre-market studies. At
    the same time, however, the article raises complex questions as to the
    proper role of the FDA as regulator, industry collaborator, and promoter
    of public health. In many respects the FDA and industry are
    collaborators – industry’s responses to new regulations are taken
    seriously by the agency, and lobby groups have long had significant
    influence over the legislation that sets the legal limits of FDA’s
    authority. Yet, the agency’s primary mission is to ensure that marketed
    products are safe and effective, though the FDA characterises itself as a
    public health agency that must “promote health, prevent illness, and prolong life”.

    As Marcia Angell, former editor of the New England Journal of Medicine, has observed, “there is growing evidence that … [the FDA] has become the servant of the industry it regulates.”

    Taken together, the articles support calls for the FDA to be more
    robust in the surveillance of marketed drugs and medical products.
    Simply stated, we need to know if the products we are using actually
    work. As the Downing study shows, the FDA’s pre-market review process
    isn’t clear on this and the public remain none the wiser.


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