Time Magazine on Data Exclusivity Debate

    By Donald Zuhn –-

A report in last week's Time magazine focuses on the ongoing debate over "an obscure but crucial health-care provision":  follow-on biologics data exclusivity -- the period of time that generic biologic manufacturers would have to wait before they are allowed to use an innovator's data to secure FDA approval for their generic biologics, or biosimilars, under a follow-on biologics regulatory pathway.  The article, entitled "How Drug-Industry Lobbyists Got Their Way on Health Care," examines the reasons behind the passage, by the House Committee on Energy and Commerce, of a health care reform amendment that would prevent the FDA from approving a biosimilar application until 12 years after the date on which the reference product -- the innovator biologic -- was first licensed (see "House Committee Approves Health Care Reform Bill Calling for 12-Year Exclusivity Period").  (The Senate Health, Education, Labor and Pensions (HELP) Committee has approved a similar amendment; see "Senators Champion 12-Year Data Exclusivity in Senate.")

The Time article nicely characterizes the dilemma facing both the House and Senate on the data exclusivity issue, stating that legislators are trying to balance the need "to foster cost-saving competition without killing the financial incentives that have put the U.S. biotechnology industry at the vanguard of medical science and without stifling the development of even more drugs that could save lives and eliminate suffering."  However, while acknowledging the adverse consequences that might result if Congress chooses the "wrong" data exclusivity period, the article seems to side with Rep. Henry Waxman (D-CA), who favors a 5-year data exclusivity period, and the generic drug manufacturers rather than with innovator companies and their army of lobbyists.  With respect to the passage of a 12-year data exclusivity period by the House Committee on Energy and Commerce -- a Committee chaired by Rep. Waxman -- the article argues that "Waxman's loss . . . was a big victory for drug companies, which have spent more than any other segment of the medical industry to make sure that they come out winners in the effort to overhaul the nation's health-care system."  The article notes that biotech/pharma companies and their trade associations utilized 1,288 lobbyists and spent more than $110 million in the first six months of the year lobbying lawmakers.  In a paragraph at the end of the article, Teva Pharmaceutials' expenditure of $2 million on lobbying is mentioned, but lobbying efforts by the rest of the generic industry or its trade associations (such as the Generic Pharmaceutical Association, where Rep. Waxman spoke on September 18th and back in February; see "Congressman Waxman Tells GPhA Meeting that Hatch-Waxman Model Will Work for Follow-on Biologics") are not explored.

In addition to Rep. Waxman's call for a 5-year data exclusivity period, the article discusses the Obama Administration's support for a 7-year period (see "White House Recommends 7-Year Data Exclusivity Period for Follow-on Biologics") and the FTC's support for no data exclusivity period (see "No One Seems Happy with Follow-on Biologics According to the FTC").  The article also mentions the study conducted by Duke University Prof. Henry Grabowski (see "Professor Grabowski's Economic Analysis of Data Exclusivity for Follow-on Biologic Drugs"), which is frequently cited in support of double-digit exclusivity periods, but notes that Prof. Grabowski's study was funded by the Pharmaceutical Research and Manufacturers of America (PhRMA) and two patient groups:

One, called RetireSafe, receives regular infusions of "general operating support" from Pfizer and operates out of a small Washington law-firm office.  . . .  The other group, the Alliance of Aging Research, is also run by the drug industry. Its chairman is the managing partner of Foxkiser, a drug-company consultant, and its vice chairman is with Novartis.

The Time article does not mention, however, that Prof. Grawbowski's study remains the only peer-reviewed analysis of the topic.

Comments

[Baltazar]

Dear Don,

So much is made of peer-review that people believe that if a study is peer-reviewed then it is correct and superior. You and I, as former lab scientist, know this is not necessarily true. We can easily find papers published in prestigious peer-reviewed journals (Nature and Science, for example) that were wrong and even retracted. I believe it is misleading to toot Prof. Grawbowski's study as better simply because it was peer-reviewed.

Patent Docs owns a responsibility to the patent community and society in general to present this issue properly. Data exclusivity for the general public and even to us patent professionals is a complex issue. As the Time article shows, the issue of data exclusivity has been twisted this way and that way by interested groups who are protecting their interest. This is wrong because whatever bill comes out of Congress will affect everyone in this country, not just these interested groups.

I understand that Patent Doc faithfully shares the views of BIO’s James Greenwood. I have no problem with this. Patent Doc is explicit to note that it is the “personal weblog of the Authors.” But Patent Doc also notes that the “Authors of "Patent Docs" are patent attorneys who hold doctorates in a diverse array of biotech and chemical disciplines.” So I would presume that Patent Doc would be more careful when picking one side of the debate and then endeavor to justify that choice. It is clear that BIO’s position in this debate is not the complete truth. The complete truth is elsewhere. I was hoping Patent Doc would lead us to that truth.

[Wer Kload]

Baltzar a/k/a an attorney for a Generics company.

[Kevin E. Noonan]

Dear Baltazar:

Now, let's be fair. We have reported on every proposal we know about, and have given post space to folks from Teva and other generics, as well as independent agents like Andrew Brill. Our consistent position is that we risk losing sight of the goal if the data exclusivity period becomes a political sticking point. Right now data exclusivity last forever for biologics; no matter how long the period (among the ones being discussed), having a follow-on pathway will be an improvement.

And speaking of Jim Greenwood, BIO supports a follow-on pathway. BIO supports 12 years of data exclusivity, although they started at 14 years and Prof. Grabowski's peer-reviewed paper says it could be as high as 16 years. (By the way, I think peer-review should get some respect, since anyone can put out a "White Paper" saying anything they want; I trust the Nature editors and reviewers enough to think the Professor's conclusions are reasonable, in view of his assumptions. Argue the assumptions and even the conclusions, but don't denigrate the peer-review process!)

So the only group seemingly not willing to compromise are the biogenerics, along with Congressman Waxman - do you think it significant that Congresswoman Eshoo has gotten about 10 times as many co-sponsors for her 12-year bill over the Chairman's 5-year bill? Congressman Waxman seems to be stuck in a 1984 time warp (and there is even evidence that the 5-year term doesn't work that well for small molecules under Hatch-Waxman).

My position has been clear - pass the bill, with 7-, 10-, 12-year data exclusivity, whatever will work, and then revisit. We will have had some time to see if the innovators are correct and they need the extra time, or of the FTC is correct and traditional "generics" companies won't enter the space, or if everyone outsources biogenerics. We will also have some time to determine whether the difference between "similar" and "interchangeable" makes a difference in market penetration, or whether it is to difficult to make safe and effective biogenerics.

Or, alternatively, any biogeneric can file an NDA today (for a biologic that is off-patent) and show the FDA they can make a safe and effective biologic drug. It should be much easier than it was for the innovator, since they should be able to use the innovator's data as a roadmap on how to show equivalence. If biologics will be a gold mine sufficient to have generic participation as well as price reduction for consumers, have at it - all we are talking about is investment costs, which can be recouped later. Indeed, if I were a well-funded biogeneric, I might want the follow-on biologic bills to fail to clear the playing field for me.

Thanks for the comment.

[Baltazar]

Dear Kevin,

I am not denigrate the peer-review process. At least I did not imply that. I was merely pointing out that peer-review does not equate to superior work. So it is not necessarily correct to place more weight on a peer-reviewed paper than one that is not. One gets a higher impression from a peer-reviewed paper because more minds have considered it. And that is where the value of peer-review ends.