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P&G launches new campaign for Swiffer line

BY Doug Desjardins

Proctor & Gamble is rolling out a new program that offers money-back guarantees and discounts on Swiffer cleaning products.

The marketing effort kicked off July 22 with ads and TV commercials using the tagline, ‘Cleans Better than a Mop and Bucket or Your Money Back.’ The ads also direct consumers to the Swiffer Web-site, where they can get a $5 discount on purchases.

The new campaign is seen as a way to boost sales of Swiffer products in a slow economy and instill consumer confidence in the household cleaning line.

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Regulations could delay Canadian generics

BY Amanda Baltazar

OTTAWA —Proposed Canadian government regulations look set to further delay the approval of generic drugs in this country, which is bad news for manufacturers, patients needing drugs and the provinces that pay for them.

The changes will mean that brand-name drug companies can reinstate drug patents and hold multiple patents on each of their products. This practice of “evergreening” is, however, considered mostly a delaying tactic against lower-priced generic drugs.

In October 2006 the Canadian government ruled that the practice of using several unrelated patents for one drug was inadmissible. A month later the Canadian Supreme Court corroborated this decision.

So for just over 18 months, Canada has been in the position of seeing more generics come to market, as brand-name patents expire.

But there were some surprises lurking in the background.

“Unbeknownst to us, the branded companies went to the government and said this was a hardship to them,” said Jim Keon, president of the Canadian Generic Pharmaceutical Association.

And the government listened, but it didn’t talk to anyone else, such as generic companies, the provinces (which pay for around 50 percent of medications) or any other payer, he pointed out.

Once the government announced its intention to reverse its former rule, this issue went out for comment. However, in another blow to the generic drug industry and to payers, the comment period was for just 15 days, a drastic shortening of the 30 to 60 days typically granted. The comment period ended May 12.

Keon described this abuse of loopholes as unfairly delaying generic competition. It also ratchets up healthcare spending. He pointed to the example of Lipitor, Canada’s highest- grossing brand-name drug, with 1.1 billion in sales in Canadian dollars every year. A generic version of the drug will mean savings of C$500 to C$600 annually, he pointed out, greatly alleviating the financial burden of Health Canada (the government department responsible for national public health).

A decision regarding the patent regulations is likely to come from the government any day now, and Keon’s not expecting much. “It seems the intent is still to go ahead [with the regulation reversal].”

However, he is hopeful that CGPA will discover that making regulations like these is beyond the government’s power. “If [the government] goes ahead, we’ll have to look at the regulations and see if we can take them to court. The speed at which they moved and the short comment time make me think that they’re likely to move quickly.”

If the patents regulation is reversed, Keon expects to see a small flood of patents coming onto a list held by Health Canada, as well as some patents being added retroactively. It’s all very bad news for generics.

“The reality is that in a country like Canada, where the drug companies have such power, the government listens to them instead of looking at what’s best for the provinces, which are the payers,” asserted Jack Kay, president of the Canadian arm of generic manufacturer Apotex. He added that the government tends to bow to the branded companies because it sees them as essential to bringing research and development to the country, rather than simply importing from the United States.

Opponents of the status quo also argue that some branded drug companies don’t stand by their promises.

When pharmaceutical patent protection in Canada was increased in 1987, brand-name drug companies promised to invest 10 percent of their Canadian revenues into research and development. However, Canada’s Patented Medicine Prices Review Board, which monitors this spending, reports that the brand-name industry has failed to meet this commitment for six consecutive years.

Kay also pointed out that since there is no 180-day exclusivity period for the first generic drug to market, this new regulation not only delays his revenues by around two years, but also allows competing generic companies to catch up.

The cost differential between brand-name and generic drugs is less than it is in the United States, although it’s still substantial. According to IMS Health, the average brand-name prescription in Canada costs C$66, while the average generic costs C$24.

Canada’s Research-Based Pharmaceutical Companies which represents branded companies and their employees, did not return calls seeking comment.

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FDA orders HFA-propelled inhalers, bans CFCs

BY Drew Buono

WASHINGTON —The Food and Drug Administration at the end of May issued a public health advisory to alert patients, caregivers and healthcare professionals to switch to hydrofluoroalkane-propelled albuterol inhalers given the coming ban on chlorofluorocarbon-propelled inhalers, which no longer will be available in the United States after Dec. 31, 2008. All inhalers instead will be powered by ozone-friendly HFAs, or hydrofluoroalkanes.

Brought on as the result of the U.S. Clean Air Act and an international treaty, the Montreal Protocol on Substances that Deplete the Ozone Layer, the inhalers are being phased out because they are harmful to the environment and contribute to the depletion of the earth’s ozone layer, which shields the planet from harmful ultraviolet radiation.

While the FDA first began warning patients of the coming change several years ago, the May 30 advisory instructs anyone still using CFC inhalers to ask their doctor about switching now.

“Concern about the environment stimulated the need to phase out CFCs,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “The FDA wants to emphasize that HFA-propelled albuterol inhalers are safe and effective replacements for CFC-propelled albuterol inhalers.”

The FDA warns that patients will face a learning curve: HFA inhalers may taste and feel different. The spray may feel softer. Each inhaler must be primed and cleaned in a specific way to prevent clogs. And—at least for now—they tend to cost more because there are no generic versions of them on the market yet.

Sales growth of aerosol beta agonists

Source: IMS Health
Beta agonists, aerosol Year 2007 total $ Year 2007 total $ % market share % growth 2007 over 2006
ProAir HFA $396,368 36.4% 399%
Albuterol 255,026 23.4 16
Proventil HFA 194,306 17.8 250
Xopenex HFA 145,958 13.4 149
Ventolin HFA 46,995 4.3 414
Total others 50,073 4.6 –9

Currently, the FDA has approved three HFA-propelled albuterol inhalers: ProAir HFA inhalation aerosol, Proventil HFA inhalation aerosol and Ventolin HFA inhalation aerosol. In addition, an HFA-propelled inhaler containing levalbuterol, a medicine similar to albuterol, is available as Xopenex HFA inhalation aerosol.

Meanwhile, as the change has been coming for some time now, last year marked a shift in sales to HFA inhalers. Prior to 2007, CFC inhalers were still the No. 1 selling drugs in the beta agonist-aerosol category. According to IMS Health, in 2006, albuterol or CFC inhalers had sales of more than $220 million, versus the HFA-propelled albuterol inhaler ProAir, which generated sales of $79.4 million, during that period. But in 2007, ProAir sales reached almost $400 million versus CFC-propelled albuterol, which ranked second, with sales of more than $255 million, according to IMS Health.

While there still is significant growth expected in the migration from CFC to HFA inhalers, it appears most of the conversion has occurred already. According to Dr. Badrul Chowdhury, director of the FDA’s division of pulmonary and allergy products, approximately 65 percent of inhaler users already have switched to HFA inhalers.

To ensure that the market for CFC inhalers drops off rapidly, Armstrong Pharmaceuticals, the sole remaining maker of CFC inhalers, is expected to stop production even before the Dec. 31 deadline. A spokesman for Armstrong’s parent company wouldn’t say when production would stop, but sales of remaining inventory will continue through the end of the year.

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