‘Third class of drugs’ could quickly become industry fighting words
WHAT IT MEANS AND WHY IT’S IMPORTANT — There is an important distinction to be made here, one that could place pharmacy operators and over-the-counter manufacturers on opposite sides of the aisle. And that’s the call for a codified third class of drugs, made more or less by both the National Association of Chain Drug Stores and the National Community Pharmacists Association in their written submissions to the Food and Drug Administration on expanding the switch paradigm. The Consumer Healthcare Products Association, in its written comments, maintains the current two-class drug system, not three-class, is the way to go.
(THE NEWS: NACDS expresses to FDA cautious optimism on the ‘new paradigm’ for third class of drugs. For the full story, click here.)
During a CHPA Annual meeting in 2007, then FDA commissioner and keynote speaker Andrew von Eschenbach captured every executive’s immediate and rapt attention when he advocated the creation of a codified third class of drugs. It was like he was advocating dog fighting at a PETA convention. Every person in that room stopped what they were doing and asked themselves, "Did he just say what I think he said?"
That’s because there is a significant danger associated with establishing a legal definition for a third class of drugs — one that would restrict access as opposed to broaden access to appropriate medicines in the self-care space, one that would prove as a disincentive to any potential switch applicant as the prospect of recouping any research and development expenditures, not to mention a profit, quickly dwindles.
There already is a stark example of a medicine that’s mandated by law to be merchandised from behind the pharmacy counter: pseudoephedrine. There are no pharmacological reasons for that "reverse switch," no safety and efficacy concerns that would preclude availability on the shelf and without a pharmacist intervention. It’s sold behind the counter because a small percentage of criminals use PSE cold tablets as one of the raw ingredients in their backyard recipes for methamphetamine. When PSE went from OTC to behind the counter, sales plummeted.
PSE also happens to serve as a good example as to why retail pharmacy would be a lot more comfortable with the inclusion of the pharmacist in any switch paradigm if there were actually a codified third class of drugs. Because the fact is many pharmacists have to "dispense" that PSE product upon request; they have to process that transaction after checking a photo ID, after obtaining the appropriate signatures and after running that transaction through the appropriate vetting system. It’s a consultation to be sure, but it’s not a consultation where pharmacists see any kind of reimbursement for their time.
Neither retail pharmacy nor consumer healthcare companies would advocate replicating this "reverse switch" example with another medicine. But that’s one danger in a codified third class of drugs. It would make it easier to take any OTC medicine that presented adverse results when misused or abused, and place that medicine into BTC status. Worried that your children are chugging dextromethorphan? Make it BTC. Concerned about those acute overdoses of acetaminophen, whether by accident or with purpose? Make it BTC.
To be sure, both DXM and APAP could be mandated behind-the-counter today. But today it takes an act of Congress to do it; there is no fast and easy mechanism that can be used to quickly move medicines back and forth between drug classes.
Retail pharmacy’s concerns are not unfounded, however. Pharmacists already play a significant role in moving the needle toward better healthcare outcomes; and in more and more cases, they are getting appropriately compensated for that professional intervention. And that needs to continue: Broader inclusion of the pharmacist in any patient’s disease-state protocol represents a big savings opportunity for health care. But they’re not volunteers; they are learned health professionals who have the same six-year-plus student loans to pay off as their nurse and doctor counterparts.
So what’s the solution? How do you create a switch protocol that a) expands access without inadvertently restricting access, b) prevents pre-existing OTC therapies from being "reverse switched" or prevents switch applicants to be forever trapped in a transitory BTC status and c) includes a mechanism through which a pharmacist can be appropriately compensated for their time? Sound off below! Or send comments to senior OTC editor Mike Johnsen at [email protected].
Amgen offers testimony at FDA biosimilars hearing
THOUSAND OAKS, Calif. — Biotech drug maker Amgen has joined the list of companies offering testimony at a Food and Drug Administration hearing on biosimilars Friday.
Amgen said Friday that it would send SVP research and development Joseph Miletich to urge the FDA panel to establish approval standards that "advance patient safety and promote confidence in biosimilars marketed in the U.S."
"While much more is known today than 30 years ago, the FDA’s guidance documents should candidly acknowledge that there are some things we still do not scientifically know today," Miletich said in a statement.
Miletich plans to make three recommendations to the agency as it finalizes its guidances: Adopt policies to facilitate attribution of adverse events and foster manufacturer accountability; conduct a communications campaign about biologics and biosimilars; and foster supply chain stability.
Sandoz, the generics division of Swiss drug maker Novartis that makes biosimilars for the European market, announced Wednesday that it would be testifying as well. The hearing relates to draft guidances concerning the development of biosimilars that the agency released February.
FDA advisory committee recommends PrEP approval for Truvada
FOSTER CITY, Calif. — An expert panel at the Food and Drug Administration has recommended that the agency approve a drug made by Gilead Sciences for lowering the risk of infection by the virus that causes AIDS.
The drug maker announced Thursday night that the FDA Antiviral Drugs Advisory Committee had voted to support approval of Truvada (emtricitabine and tenofovir disoproxil fumarate) for pre-exposure prophylaxis, or PrEP, in adults. With PrEP, a person would take the drug every day in order to reduce his or her risk of becoming infected with HIV. Doctors often prescribe the drug for PrEP, but it has yet to win FDA approval for that use. Clinical trials have indicated that the drug is effective in preventing HIV infection through sexual activity, but whether it prevents infection through intravenous drug use remains unclear, and studies of that are ongoing.
The committee’s recommendation was based on studies showing that the drug reduced infection risk among men who have sex with men, also known as MSM, by slightly less than 44%, while reducing the risk by between 62% and 73% among men and women at high risk of infection in Botswana and among uninfected partners in Kenyan couples that were serodiscordant, in which one partner is HIV-positive and one is HIV-negative.
The committee voted 19-3 in favor of approval of Truvada for PrEP in MSM; 19-3 with one abstention for preventing infection of uninfected partners in serodiscordant couples; and 12-8 with two abstentions in other people at risk for contracting the virus through sexual activity.
Thursday’s vote brings the drug one major step closer to approval for PrEP, and the FDA plans to decide whether or not to approve on June 15; it doesn’t bind the FDA to grant approval, but the agency usually follows advisory committee votes.
Still, the practice of using PrEP remains controversial, and many healthcare professionals and AIDS advocates have expressed concerns that widespread use of PrEP could decrease condom use, as well as concerns over adherence to PrEP, with many urging the FDA advisory committee not to recommend approval, according to published reports. A 2010 study conducted by psychology researchers at New York’s Hunter College among 180 HIV-negative MSM considered to be at high risk of contracting the disease found that almost 70% reported a willingness to use PrEP if it were at least 80% effective in preventing HIV. But of those, more than 35% said they would be likely to decrease condom use while on PrEP.
The AIDS Healthcare Foundation has also opposed approval of Truvada for PrEP, citing the 44% infection-prevention rate, compared with 98% for condoms while also expressing concerns that its use could lead to drug-resistant HIV strains, while some officials at the Centers for Disease Control and Prevention have said PrEP could create a false sense of security among high-risk groups.
According to market research firm GlobalData, Truvada had sales of $2.88 million in 2011, but with 415,000 Americans identified by the CDC as being at high risk of HIV infection, an FDA approval of the drug for PrEP could increase that figure significantly.