Roll Call Authors Unite against Current Follow Biologics Legislation

    By Donald Zuhn --

Earlier this month, James Love and James Glassman, writing in the Congressional newspaper Roll Call, expressed "alarm" regarding recent Congressional action concerning the establishment of a follow-in biologics (FOB) regulatory pathway ("Don't Kill Competition for High-Tech Drugs").  That action included the recent passage by the House Committee on Energy and Commerce of a health care reform bill containing a licensure pathway for biosimilar biological products that would prevent the FDA from approving a biosimilar application until 12 years after the date on which the reference product (i.e., the innovator biologic) was first licensed (see "House Committee Approves Health Care Reform Bill Calling for 12-Year Exclusivity Period"), and prior approval by the Senate Health, Education, Labor and Pensions (HELP) Committee of an amendment providing a 12-year data exclusivity period for biologic drug makers (see "Senators Champion 12-Year Data Exclusivity in Senate").

James Love (at right), the director of the public interest advocacy group Knowledge Ecology International, and James Glassman (below left) the former under secretary of State for public diplomacy and public affairs in the George W. Bush administration and editor of Roll Call from 1988-93, contend that passage of FOB provisions by the House Energy and Commerce and Senate HELP Committees would "make it difficult, if not impossible, for generic drugs to compete with biologics, even after patents have expired."  The authors add that these provisions, if reconciled and passed into law, have "the potential to harm millions of sick people, in the United States and beyond."

Mr. Love's and Mr. Glassman's assertions are based on a comparison of the predicted impact of the House and Senate provisions with that of the Hatch-Waxman Act, which they note provided "streamlined procedures [that] lowered the cost of entry by generic suppliers and created a highly competitive environment that has saved consumers billions of dollars."  According to the authors, the FOB regulatory pathway currently being proposed by Congress is "deeply flawed and will reduce, or even eliminate, potentially significant savings to consumers."

Mr. Love and Mr. Glassman make it clear that the "flaw" in the process is the exclusivity period, which unlike the 5-year period for small molecule generics under Hatch-Waxman, at present stands at 12-years for biogenerics.  They state that "[t]he original proposal for biogenerics would have retained most of the features of the 1984 Hatch-Waxman Act, including the five-year exclusion [i.e., exclusivity period]."  However, their assertion is not entirely accurate, since one of the two House FOB bills introduced last spring (H.R. 1548) called for up to 14.5 years of exclusivity (see "Second Follow-on Biologics Bill Is Introduced in House").  It also disregards the White House's call, in June, for an exclusivity period longer than 5 years (see "White House Recommends 7-Year Data Exclusivity Period for Follow-on Biologics").  Instead, the authors argue that "after an intense lobbying campaign by the manufacturers of biologics, new amendments to the Senate and House versions of the bill made it much more difficult for makers of generics to enter the market."  Again, this statement is somewhat disingenuous in that it ignores the fact that Rep. Anna Eshoo (D-CA), who helped introduce the 12-year amendment in the House Energy and Commerce Committee, also introduced H.R. 1548 last spring as well as a similar bill in the last Congress (see "New Follow-on Biologics Bill Introduced in the House").  Thus, Rep. Eshoo did not succumb to "an intense lobbying campaign" in introducing the amendment, but rather has been pushing for a double-digit exclusivity period since March of 2008.  (In fact, in proposing a 12-year period, Rep. Eshoo actually backed off the longer period she had been seeking.)

Noting that "Members of Congress from both parties have claimed that long monopolies are needed to stimulate investments in research and development," the authors declare their strong disagreement with this position.  Although they acknowledge that developmental costs for new biologics are "undoubtedly expensive," they contend that "this is just as true for products that the FDA classifies as 'small-molecule,' or conventional, drugs as it is for biologics."  Mr. Love and Mr. Glassman also argue that "innovation has prospered under the Hatch-Waxman regime."  Biologic manufacturers, however, would likely disagree with these assertions, and Amgen Inc. Vice President and Law & Intellectual Property Officer Stuart Watt did just that last March in a presentation at the Biotechnology Industry Organization (BIO) Intellectual Property Counsels' Committee (IPCC) conference (see "Amgen VP Makes Case for Longer Exclusivity Period in Follow-on Biologics Legislation").

Mr. Love and Mr. Glassman conclude their article by noting that while Article I, Section 8, Clause 8 of the Constitution confers upon Congress the power "[t]o promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries," the Founders "understood the need for balance in creating monopolies that were temporary" -- i.e., which existed for limited times.  The authors state that "[e]ndless monopolies, particularly those created by regulatory measures, must be avoided," concluding that "a 12-year exclusion simply does not meet the test of logic."

Comments

[TJ]

Innovator pharma on one hand claims that biological products are more complex as well as making a generic will need more investment + time. Looks like the FDA and generally everyone too agrees. Typically, this ought to result into fewer generic companies, pursuing less bio products when compared to the small molecule situation even with the same 5 year data exclusivity. Strangely, the same companies in the same breath argue for a data exclusivity period which is 2.5 to 3 times that for small molecule NCEs. Intriguingly, the politicians, unmindful of their duty towards the citizens, seem to have bought this entirely preposterous line of argument of the innovator pharma. We just hope better sense prevails, sooner than later. President Obama seems to be the last hope on this matter.

[EG]

Don,

The post says that Love and Glassman are concerned that the current FOB legislation has "the potential to harm millions of sick people, in the United States and beyond." But did Love and Glassman address the bigger and potentially more scary issue that Kevin noted about how to determine when a FOB is "biosimilar" to avoid a potential "pure red cell aplasia" issue like Europe encountered in 2001? Again, these two folks appear to be focused strictly on the speed and cost of biologic drugs while ignoring the safety concerns these FOBs raise if the standard for "biosimilar" isn't strict enough.

[Donald Zuhn]

EG:

Love and Glassman did not address the issue of bioequivalance, but as you note, focused on the length of the proposed exclusivity period and how his would impact the introduction of biogenerics. Setting aside the difficulties in determining whether a biogeneric is equivalent to a biologic, and the related issue of whether an FOB is as safe as an innovator's biologic, the authors' focus on short-term costs savings disregards the impact of a 5-year exclusivity period on long-term innovation. When a regulatory pathway is being created where none currently exists, and as a result, generic drug companies are allowed to use an innovator's data to expedite approval where they currently cannot, it is not sufficient to merely state that innovation will be fine with a 5-year exclusivity period. Rather, proponents have the burden of establishing through studies and economic analyses that innovation will be fine. At Patent Docs, we try to write up every study we can get our hands on, and so far there have been very few that have attempted to demonstrate that exclusivity periods of 5 years or less will not adversely impact innovation.

Thanks for the comment,

Don

[Keep It Real]

Why not let the free market take care of the safety concerns? As long as the public knows the risks, what's the problem? You know, like those expensive TV commercials that Big Pharma uses to push drugs on people? Just hire some fast talker to recite a bunch of "buyer beware" legalese at the end and it's all good.

[Donald Zuhn]

You mean like we let the free market take care of home financing?

[EG]

"the authors' focus on short-term costs savings disregards the impact of a 5-year exclusivity period on long-term innovation."

Don,

Couldn't agree with you more. As Kevin has said, there is no FOB pathway now, so the burden should be on those who want it to justify that "data exclusivity" periods of only 5 years won't impact development of biologic drugs. And as you correctly point out, the evidence supporting periods as short as 5 years having no impact is sorely lacking. Instead, all we hear is rhetoric about speed, cost, and the "harm" to so many millions of sick. It would be ironic if those "many millions of sick" suffered because the "data exclusivity" period was so short that no one even developed the biologic drugs because of insufficient ROI.

[Kevin E. Noonan]

Dear TJ:

Different timeframes is the answer to the seeming conundrum. The biogenerics have the innovators to copy, and so the issue is how well they can do it and when they should be able to use the innovator's safety and efficacy data. The innovators had to develop the biologic drugs in the first place, which takes a greater amount of time and investment (including not only R&D costs but building manufacturing plants to make the specialized biologic drugs, for example). As a result, there must be sufficient ROI to support these efforts.

No contradiction, just the difference between being the first to develop a new biologic drug and being a follow-on.

Thanks for the comment.

[Gena777]

The courts have interpreted the Constitution's "Limited Times" Clause as a check on the potential monopolization of patent rights and other IP. Double-digit exclusivity periods seem to conflict with this inferred intent. I appreciate the suggestion about implementing different time frames for innovators and generics; I hope this option becomes part of the continued discussion on this topic.
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