What if Teva Pharmaceuticals just said, "Thanks, anyway, but we'll skip the whole Plan B One-Step thing?"
Yes, after more than a decade of being near the center of legal, political, social, business and even religious debate about the over-the-counter availability of morning-after contraceptives, what if Teva Pharmaceutical Industries, Ltd., just decided it was too much bother - and insufficiently profitable - to produce Plan B One-Step?
This is just a theory, which could fall apart several places, but stay with me.
The whole debate flared again Monday night and Tuesday, after the Obama Administration seemed to concede that it was going to lose all or part of its argument in federal court in Brooklyn and with the U.S. Court of Appeals for the Second Circuit.
(A link to Wednesday's Inquirer print story is here. Brady Dennis and Sarah Kliff of the Washington Post reported Monday night on the Obama-White House thinking on the matter. Link here.)
The Justice Department told District Court Judge Edward Korman that it would comply with his orders, but only in its way. Seizing on possibilities that Korman raised and perhaps thought were remote, the government basically said it would approve Teva's Plan B One-Step, which is a single pill, for use for anybody and available on the shelf. But the government said it will keep cheaper, two-pill generics behind the counter, require a prescription and ID with age for those under 17, as it does now.
The Justice Department, via the Food and Drug Administration, also said it would likely see revised applications from generic competitors to Teva as those companies hope to sell their versions of Plan B One-Step to all age groups.
But therein lies the rub: Teva might only want to play solo in this drama.
On April 30, in what Korman called a "sweetheart" deal, Teva got three years of exclusivity from the FDA to sell its Plan B One-Step pill to girls age 15 or 16, as long as they showed ID at the cashier. No prescription was needed. They could buy the pills late at night, perhaps after a party that got too festive for anyone's good. It wouldn't matter that the 24-hour drug store's pharmacy was closed because they don't need a prescription. And in that scenario, only Teva's product would be on the shelves.
Locked up behind the pharmacy counter.
But did that cause a stir in the financial markets?
No. As noted in a May Inquirer story (link here), Plan B One-Step was not mentioned during the May 2 conference call between company officials and Wall Street analysts, where the billion-dollar multiple sclerosis drug Copaxone dominated discussion.
"Some business is just not worth the trouble," Erik Gordon, a University of Michigan business professor who follows the pharmaceutical industry, told the Inquirer for that May story. "You make 5 cents and get a punch in the nose. Plan B isn't the only example."
Fast forward to Monday and Tuesday.
Very clearly, the Justice Department said in a letter to Korman that if Teva re-submits an application to sell Plan B One-Step to anyone of any age, the FDA “will approve it without delay.”
The FDA said it will also review re-submissions by generic competitors wanting to sell their versions of Plan B One-Step.
The FDA also said in its portion of the letter that it might grant Teva exclusivity, just as it did on April 30.
That could give Teva a big financial edge over competitors in that market.
If the FDA gave Teva three years to sell morning-after pills from the shelves to anyone of any age without a prescription - and without competition - Teva probably could make a good chunk of change.
The White House would also achieve some of its goal of limiting the number of teenagers who might be buying emergency contraception.
Teva’s Plan B One-Step had $82 million in sales in 2012, according to IMS Health, a health-care technology and information company.
Teva does not break out individual drugs in its Women's Health unit. But in the financial report it filed with the Securities and Exchange Commission for the first quarter of 2013, Teva said the entire unit had only $103 million in sales, a decrease of 5 percent from the $108 million it had in the same period of 2012. A link is here. The link to the report is here. And now we quote, in part:
"The decrease was primarily due to lower sales in the United States of our emergency contraceptive Plan B One-Step, resulting from generic competition beginning in the third quarter of 2012."
In the fall of 2012, Actavis began selling Next Choice One Dose, its generic version of Teva's Plan B One-Step.
Women's groups who have fought the legal battle for more than a decade were happy that the White House made the step it did Monday night. Amy Allina, the Program and Policy Director of the National Women’s Health Network, referred to it as untying the latest "knot" in the entanglement. But she and others were very suspicious that the government was not making all morning-after pills available over the counter.
"Now we have to make sure that business interests do not trump women's health needs," Allina said in a conference call.
Allina and her colleagues want Teva and many generic competitors, whether it is one pill or two (as long as they are safe and effective), because that will lower the cost. Plan B One-Step will cost about $50.
But Teva - like every drug company - profits more from exclusivity and will sometimes abandon drugs that no longer generate enough cash.
Lipitor and Plan B.
So many generics flooded the market after Pfizer's cholesterol blockbuster Lipitor lost patent protection that Teva eventually took a pass.
And though the total revenues were much smaller, the same thing happened with the original Plan B. Teva is the original "sponsor" (in FDA terms) of the two-pill version. But when generic competitors cut margins, it stopped marketing Plan B and focused energy on one-bill version called Plan B One-step.
FDA spokeswoman Erica Jefferson declined comment when asked whether Teva would get exclusivity a second time.
Among other questions, we asked Teva spokeswoman Denise Bradley whether the company would sell Plan B One-Step if it didn't have exclusivity for three years.
"We have no comment at this time," Bradley said via email.