NHC’s 40th Anniversary in 2018

New Year’s message from our Chairman & CEO Nicholas Hall:nh

The start of a new year, and already there is a big ripple of activity in the global CHC market. MM&M NewsBrief ran a story on Tuesday headlined: “CPG companies Nestle and Kellogg court OTC”. It is an interesting notion that Kellogg could buy into the mainstream CHC market as their previous forays have focused on functional foods. But it seems a stretch to me, although there would be a certain neatness if Steve Cahillane, the new CEO of Kellogg and formerly Nature’s Bounty President & CEO would bid for Pfizer Consumer, where Paul Sturman was President. And where is Paul now? — Steve’s replacement at Natures Bounty.

So, it’s possible but unlikely that Steve will become a New Friend (or more properly a Friend Reunited), but our New Friend at FDA, Scott Gottlieb, is making interesting noises that could potentially liberalise the rather static US market. Could this include a new 3rd Class, about which I have been a lone voice in the wilderness for almost all of my time in the CHC industry (more on that later)? CHPA and other stakeholders (apart from retail pharmacy) say “No” as this is illiberal. Mmm, I think the other way. Switching more Rx products under the personal supervision of a pharmacist is very liberal, and will certainly lower costs, which is empowering for consumers — a key test of liberalism. And rounding up the last of our New Friends in this New Year issue, let’s welcome Amazon as a CHC brand marketer, not just an online platform. Some would say, who needs friends like Amazon? Well, I would rather have Amazon as a Friend than an Enemy!

Two prominent association leaders are leaving the industry, the Departing Doctors Gerald Dziekan and Hubertus Cranz. They have done amazing work, as my Good Friend Birgit Schuhbauer relates below, and will be very much missed. I hope the NHC Group will have good or possibly even better relations with their successors. Another Departing Friend who will be particularly missed is Senator Orrin Hatch, who did so much to override FDA when we had no friends there at all. Former presidential candidate Mitt Romney will probably succeed to the Utah seat of Senator Hatch. I hope that the man who made millions at Bain will be as — or even more — sympathetic to CHC.

What about Remaining Friends? Well, that’s us. I almost can’t believe it, but we set up NHC in January 1978. Indeed, a few minutes ago one of my Very Best Friends sent congratulations on our 30th Anniversary. Obviously we were having too much fun to count! I still have clients and colleagues from that era, including the redoubtable Gilbert (Sans Frontieres) Mertens, who still comes to our conferences and last year was our guest in Singapore. 40 years is an amazing length of time, but we at NHC are all about the Future.

So after many years of some change and a lot that’s still the same, good or bad, it is with very great pleasure that all of us at NHC Group wish our contacts a Happy New Year for the 40th time. May it be one of good health, great happiness, peace, success and prosperity. We will be here for another 40 years (at least corporately) and we hope you will be too!!

World first digital pill gets FDA green light

OTCINACTION

Otsuka (in association with Proteus Digital Health) has been granted approval by the US FDA for Abilify MyCite, the world’s first digital pill, which contains a sensor that tracks when the medicine has been ingested by the patient. Though Abilify is an Rx medicine for schizophrenia and bipolar disorder, its approval has far-reaching implications for both prescription drugs and consumer healthcare.

How it works: Containing a sensor the size of a grain of sand, Abilify MyCite emits an electrical signal when it comes into contact with stomach acid, and this signal is received by a patch on the patient’s rib cage. In turn, this patch communicates with a smartphone app via Bluetooth, providing data such as time of ingestion and dosage. As well as the doctor and patient, up to 4 other people (including family members) can have access to the app’s data – though, importantly, the patient has control and can revoke access.

 

Mitchell Mathis, Director of the Division of Psychiatry Products at the FDA’s Center for Drug Evaluation & Research, said: “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.” Inevitably, during the initial phase, the digital pill will be incorporated solely into Rx medicines – to allow the FDA to monitor its impact on safety and adherence – however, at a later date, there is nothing to stop this new technology being part of innovative Rx-to-OTC switches.

Patients, doctors and insurers are increasingly coming to appreciate the ability to access objective data about the whole range of our medical consumption – from Rx drugs to OTCs and supplements. Once the price of these new sensors is reduced to a certain level of affordability, we could see a much wider rollout of the technology.

That said, a major stumbling block could be the issue of privacy. Some are concerned that patients who fail to take their medicines on a regular basis may be punished by their health insurers, while others have worries that the technology could be used as a coercive tool against certain types of patients. However, those concerns aside, the future for healthcare looks increasingly digital and the FDA is already hiring more staff in anticipation of a raft of new applications for digital pills.

IBIS AND HRA AIM TO SWITCH THE PILL TO OTC

Ibis Reproductive Health and French-based HRA Pharma are working together to provide the research needed to submit an application to the US FDA to switch a progestin-only daily use oral contraceptive (OC) to OTC. For over a decade Ibis has worked with a broad coalition of healthcare providers, advocates and researchers in the Oral Contraceptives OTC Working group to build the evidence and make the case for the benefits of moving a birth control pill OTC.

Ibis highlights that too many people in the US face barriers to accessing the birth control they want and that a safe and effective OC would help people overcome some of those barriers. The coalition is committed to conducting the research and advocacy to ensure any OTC method is covered by health insurance and available to everyone who needs it.

HRA Pharma has already seen success in Rx-to-OTC switch in the EU, with its application to the European Medicines Agency to reclassify its emergency hormonal contraceptive ellaOne (ulipristal acetate 30mg) approved by the European Commission in early 2015 via the centralised procedure.

In an exclusive comment to the OTC.NewDirections team, Ibis Reproductive Health’s VP for Development & Public Affairs Britt Wahlin said: We are thrilled to be working with HRA Pharma in this effort that has been driven by demand from consumers and medical professionals. It’s past time we have an FDA approved OTC birth control pill, which would make it easier for women and men all across the country to determine how and when to have children and give them greater control over their lives and reproductive health. Currently, under the Affordable Care Act, most private insurance plans have to cover all types of FDA-approved birth control for women without any cost-sharing. This includes OTC methods used by women – though only if a healthcare provider prescribes them. We hope that women will be able to use their insurance for an OTC birth control pill without having to get a prescription.

A new law in Maryland is a promising direction. It will require coverage of OTC contraceptive medications without a prescription starting in 2018 and we hope more states will follow suit. Efforts are underway to dismantle the ACA and we have yet to learn what concrete plans there are to replace it. The birth control coverage provision is a crucial piece of the ACA. Millions of women have benefited from greater access to birth control and contraception is not one size fits all; insurance coverage of the full range of methods is critical so that women truly have a choice.

ibis-reproductive-health.jpg

Also, HRA Pharma’s US Portfolio Strategy Director Stéphanie Pradet told the OTC.NewDirections team: HRA Pharma is proud to partner with Ibis Reproductive Health and the OC OTC Working Group to bring to the US market a safe and effective over-the-counter contraceptive. At HRA, we are proud of our pioneering work to expand access to contraception for millions of women. We share the OC OTC Working Group’s commitment to increasing safe and effective options for preventing pregnancy and improving the reproductive health of women in the US.

Oral contraceptives are some of the best-studied medicines on the market today and enjoy longstanding support from medical and public health experts. The science is clear, and US experts including The American College of Obstetricians & Gynecologists, the American Medical Association and the American Academy of Family Physicians agree that oral contraceptives are appropriate as an over-the-counter option. We look forward to working together to build a future where each woman can get the safe and highly effective birth control method she prefers.

Male Contraceptive Has Moderate Trial Success

OTCinActionheader

The next frontier of sexual liberation is close – the male contraceptive is almost here!

For decades now, scientists have been progressively working towards developing birth control for men, and the recent news that the injected male contraceptive is now just as effective as its female counterpart is groundbreaking.

In a trial of 320 men, aged between 18 and 45, researchers found that, over a one-year period, a new hormone-based injection was 96% effective in preventing pregnancy.

The hormones injected into the men on the trial were shown to dramatically lower their sperm count by “switching off” the male reproductive system.

The drugs did however cause some unpleasant side-effects, meaning that the trial had to be halted early. Of the 320 participants, 20 experienced mood swings, depression, muscle pain and acne. Despite this, 75% of the participants said they would be happy to take the male contraceptive on a regular basis.

Male contraceptive.jpg

Richard Anderson, a professor of clinical reproductive science and author of the study, said: “If you’re comparing it to other reversible male methods, it’s far better than the condom and it puts it in the same ballpark as the pill.”

The male contraceptive is not the only new and innovative form of protection that is set to be on offer. The predominantly male condom is now available in female form. The disposable contraceptive device, which is marketed by The Female Health Company, is the only female condom approved by the US FDA and cleared by the World Health Organization.

The condom provides dual protection against unintended pregnancy and sexually transmitted infections, offering what it claims to be a thoroughly safe sexual experience for both parties.

OTCs in Action: US access to OCs changing

OTCinActionheader

Digital Projects Executive, Holly Parmenter, looks at how access to oral contraceptives is evolving in the world’s No.1 OTC market.

It’s legitimate; three US states now officially allow you to get your daily birth control straight from your pharmacist at the local drugstore.

This week OTCs are in action in Oregon, Washington and California as these states have agreed to the new pharmacist-prescribed hormonal birth control plan; Hawaii, Missouri, South Carolina and Tennessee are all in discussions as to whether to follow.

Gone are the days where waiting and queuing for your contraceptives was a necessity – the entire process, start to finish, now takes just under 20 minutes!

This new and exciting development consists of filling out a simple health questionnaire and having your blood pressure taken. Your pharmacist will then recommended a brand of birth control pills. It has been on the cards for a while, as women’s healthcare providers have expressed how they would like to see birth control made easier to access.

birth-control-teeth-health-400x400

The matter, over various states, has been considered very political. Applications for switch must also show that the candidate is very safe in terms of health. With a large amount of oral contraceptives, there is a thrombotic stroke risk, and an applicant would have to be able to deal with this through labelling if, for example, progestin-based pills were to become OTC.

In June 2015, US Senator Patty Murray announced the Affordability is Access Act, a new bill that would build on contraception coverage mandated in the Affordable Care Act. “I believe strongly that women should be able to get the comprehensive healthcare they need, when they need it
 – without being charged extra, without asking permission and without politicians interfering,” said Senator Murray.

With support from NARAL Pro Choice America, Planned Parenthood Action Fund and the American Congress of Obstetricians & Gynecologists (ACOG), the Affordability is Access Act would allow women to have access to OTC OCs without being forced to pay extra out of pocket.

So far there seems to be no movement on this merging but here’s hoping that now California, Washington and Oregon have this OTC offering, the positives will become apparent and various partnerships can work together to make OCs truly OTC nationwide.

OTCs in Action Episode 47: Natural Sucanon approved to treat Type II diabetes

OTCinActionheader

Last week, OTCs were in Action in Canada, where Sucanon has been evaluated by regulatory authorities, and is now a licensed natural health product for treating Type 2 diabetes.

Marketed by PharmaRoth Laboratories, Sucanon is an insulin sensitiser, lowering a patient’s blood sugar by increasing the muscle, fat and liver’s sensitivity to the body’s own naturally produced insulin. The product is also available as an OTC in Mexico, but has Rx status in China and Peru.

Last year, the US FDA denied PharmaRoth’s New Dietary Ingredient application for Sucanon to be sold as a nutraceutical. According to the US agency, the active ingredients, derived from a dried root and a form of molybdenum, should be classified as a drug.

OTCs in Action will be watching with interest this product’s expansion to various countries as PharmaRoth seeks to give diabetics access to safe and effective treatment. The brand’s tagline is:

Sucanon … Diabetes is not curable but is treatable … enjoy life.

OTCs in Action Episode 42: Homeopathy win in California generates ripples in Baltimore

OTCinActionheaderOTCs were in Action on Friday in California, where a jury found that homeopathic giant Hyland’s (Standard Homeopathic) did not mislead thousands of consumers into believing that its products are effective for ailments including allergies, leg cramps, migraines and sleeplessness. The effect was immediately felt at the Natural Products Expo in Baltimore, as the news was texted back East to colleagues in the homeopathy and natural products fields.

In recent years, the level of new homeopathic OTC-branded products in the show has seemed to decline, possibly owing to unresolved legal and regulatory issues. This August, for example, the Federal Trade Commission recommended that the FDA revise its 1988 Compliance Policy Guide framework for regulating homeopathics to align with FTC requirements on advertising substantiation. It’s almost perfect timing that today, the FTC is hosting a workshop to evaluate the advertising of OTC homeopathic remedies.

Last Friday’s verdict was notable in that many smaller cases against homeopathy marketers are settled out of court. This major class action decision is perceived as a win for the industry. Specifically, the unsuccessful lawsuit alleged: “Hyland’s sells its homeopathic remedies without explaining to customers that at their practiced dilution levels, “very little, if any” of the advertised active ingredients are present,” reported Law360 on Friday.

During his closing arguments, Hyland’s attorney, Jeffrey Margulies, told jurors that the plaintiffs had a high burden of proof because in order to find that the representations on the product and packaging were false, jurors would have to be convinced that “the products do not perform as promised, because they cannot perform as promised.” Margulies pointed to Hyland’s surveys that show their products have an across-the-board 94% customer satisfaction rating.

OTCs in Action Episode 36: Naloxone to the rescue

OTCinActionheaderAccording to the World Health Organization, around 69,000 people die from opioid overdose each year. Timely administration of the Rx drug, naloxone, can counteract the effects of overdose – although tragically, most overdoses occur far from a medical setting. Last week, Health Canada announced that it is working with local governments in provinces and territories to assess the rescue drug’s Rx-to-OTC switch, while Adapt Pharma Limited submitted a New Drug Application to the US FDA for Narcan (naloxone) Nasal Spray. An FDA workshop earlier this summer focused on expanding access to naloxone and the injectable delivery of the drug – was seen as a barrier to switch.

site of overdose

Source: CDC, Adapt Pharma, LLC

The overdose crisis and the generic availability of naloxone is creating the bottom-up model of switch. Traditional Rx-to-OTC switches are manufacturer-driven, with clinical and actual use studies conducted by drug owners and submitted to regulatory bodies. In the case of naloxone, expanded access is already being expedited at local government level in the US and Canada. In the beginning of 2015, California joined New Mexico, Washington, New York, Rhode Island, and Vermont in making naloxone available from pharmacists without a prescription. In many states / provinces and cities in the US and Canada, programmes equipping emergency first responders, including police officers, with naloxone, have been highly successful. Addiction clinics also provide opioid users with take-home naloxone kits and training for their families and friends in how to inject it in case of an opioid overdose. Data collected at local level should provide Health Canada and the FDA with compelling evidence in favour of an Rx-to-OTC switch of naloxone.

OTCs in Action Episode 32: ED in NZ, not .com

OTCinActionheaderIllegal internet sales of Rx and OTC drugs, as well as adulterated dietary supplements, put consumers at great risk. “Tainted Sexual Enhancement Products”, published on the FDA’s website, warns consumers:

“The FDA has identified an emerging trend where over-the-counter products, frequently represented as dietary supplements, contain hidden active ingredients that could be harmful. Consumers may unknowingly take products laced with varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients. These deceptive products can harm you! Hidden ingredients are increasingly becoming a problem in products promoted for sexual enhancement. Remember, FDA cannot test all products on the market that contain potentially harmful hidden ingredients. Enforcement actions and consumer advisories for tainted products only cover a small fraction of the tainted over-the-counter products on the market.”

Last week, this blog’s sister publication, OTC.NewDirections, reported that an international crackdown on  illegal internet trade of medical products yielded $81.8mn worth of items from 115 different countries, and 156 arrests. In the UK, a record $25.1mn worth of counterfeit and unlicensed medicines and 15,000 devices was seized, including potentially harmful slimming pills, erectile dysfunction, anaemia and narcolepsy tablets. The US FDA took action against 1,050+ websites that illegally sell potentially dangerous, unapproved Rx medicines and medical devices.

In fact, regulators around the world are playing a high stakes game of Whack-a-Mole, a popular arcade game in which players hit cheeky little moles with mallets, but as soon as one is knocked out another appears elsewhere.

WHACK A MOLE_0However, the risky business is driven by consumer demand, and now OTCs are in Action in New Zealand to satisfy those needs safely and legally. One of the more common unapproved ingredients in the FDA’s list of adulterated products is sildenafil, more commonly known by its legal Rx brand name, Viagra. The Rx-to-OTC switch of Silvasta (sildenafil) erectile dysfunction treatment in New Zealand was approved in late 2014. Men aged 35-70 years can purchase Silvasta without an Rx following a screening process with a trained pharmacist. This spring Nicholas Hall & Company awarded Douglas Pharma its top marketing award for the launch of Silvasta. A consumer campaign includes TV ads featuring an “everyday” man explaining that help is at hand from pharmacies without the need to see a doctor, while a pharmacy finder website directs men to the nearest outlet.

Another interesting development that will ensure consumer access to safer drugs is the UK’s new requirement that online medicine sellers must be registered with the Medicines & Healthcare products Regulatory Agency. They must display on every page of their website the new European common logo, which will be linked to their entry in the MHRA’s list of registered online sellers. The medicine being offered online must be licensed in the member state where the purchaser is based, and the seller must be legally entitled to sell medicine in accordance with UK legislation. Registered pharmacies can sell general sales list and pharmacy medicines or supply Rx-only medicines that they have dispensed against a prescription. Other retailers can only sell GSL (self-selection OTC) products. The penalty for disobeying the registration and logo rules is up to two years in prison, a fine or both.

In an somewhat related matter, as it affects consumer safety and appropriate use of OTC medicines by reducing illicit methamphetamine manufacture, Acura Pharmaceuticals has entered into an agreement with OTC cold remedy giant Bayer to license its IMPEDE technology. IMPEDE technology, which is available in the US in Acura’s Nexafed, has demonstrated significantly reduced yields of methamphetamine compared to traditional formulations in lab tests and has been associated with a reduction in meth labs in local markets of up to 90%. OTCs in Action covered the launch of Acura’s Nexafed Sinus Pressure + Pain (pseudoephedrine and acetaminophen) in February.

Episode 17: Outwitting meth manufacturers

OTC in Action Episode 26: Honing in on homeopathy

OTCinActionheader

Last month, OTCs were in Action at a US FDA meeting, where eminent naturopathic physicians and captains of the homeopathy industry defended the current regulatory structures for the drugs, and a few sceptics were concerned with the lack of scientific-based evidence for compliance. This venerable segment of the market has long been ignored by the agency but the increasing popularity of homeopathy, the introduction of pseudo-homeopathic dietary supplements, as well as inappropriate treatment claims such as asthma, have put the alternative treatments in the spotlight.

Back in 1938, the Food, Drug & Cosmetic Act recognised the US Homeopathic Pharmacopeia as the official compendium containing monographs for homeopathic drugs. Fifty years later, The Compliance Policy Guide (CPG) gave the FDA authority to effectively police the homeopathic medicine trade for compliance in terms of appropriate OTC claims, product safety and GMP. The Federal Trade Commission helps regulate claims and advertising.

According to the CPG: The practice of homeopathy is based on the belief that disease symptoms can be cured by small doses of substances which produce similar symptoms in healthy people.

Although the efficacy of homeopathic drugs will be debated forever, the issue is further clouded by the fact that some  OTC “homeopathic drugs” are not prepared with homeopathic methods of dilution, but make a homeopathic drug claim based on having a plant source. This allows these pseudo-homeopathic products to avoid dietary supplement status and the required disclaimer: “These statements have not been evaluated by the Food & Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.” It also crosses the firm line stated by Paul Mittman, Southwest College of Naturopathic Medicine & Health Sciences: A homeopathic is a drug and a dietary supplement is a food.

This is just the beginning of the FDA’s evaluation of homeopathic products, with written comments accepted until 22nd June — and it’s likely there will be some harsh and sceptical comments on homeopathy received by the FDA. However, given the entrenched status of homeopathy as a viable alternative therapy practiced by medical professionals, as well as a relatively safe profile as a mass market OTC, will the FDA overhaul their regulation? Written comments are welcome here as well!

Full coverage of the meeting will be published in the May issue of OTC INSIGHT North America.