Congress must light the way for biologic drugs’ approval

Medical science and legislation are colliding in Congress over the development of biologic drugs. The debate pits the hope of lower-cost “follow-on biologics” (FOBs), which would be available to more patients, against the complex science of using living tissue to create new treatments.

Biologics are made from organic material such as animal tissue and microorganisms, and are among the most effective medicines for treating diabetes, cancer and other diseases.  Biologic drugs provide treatments for debilitating illnesses that hitherto were unavailable. But how FOBs are approved presents a clear case of legislation catching up with science. Unlike Europe, there is no standard approval process for FOBs in the U.S. Instead, the Food and Drug Administration examines FOB applications on a case-by-case basis.

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There are competing bills in Congress to create an approval process for FOBs. Some policy makers embrace the proposal by Rep. Henry Waxman (D-Calif.), chairman of the House Energy and Commerce Committee. Others back the bill drafted by Rep. Anna Eshoo (D-Calif.). They differ primarily on how long companies could market their drugs before FOBs could be manufactured — Waxman’s bill would allow five years while the Eshoo version provides 12 years. In the upper chamber, Sen. Charles Schumer (D-N.Y.) has introduced a companion to the Waxman proposal and Sen. Edward Kennedy (D-Mass.) plans to reintroduce his FOB bill, which is similar to Eshoo’s blueprint.

The relative merits of each bill notwithstanding, the issue of drug safety must be addressed. Biologics are far more complicated than traditional chemical-based drugs. These drugs can be safety manufactured and, provided they are properly synthesized with the right chemicals, result in a generic that is identical to the original drug.

This is not so with biologics. Complex genetic engineering is required to produce biologics. Even minor changes in how biologics are made can result in significant changes involving the drug’s efficacy and safety. The nature of biologics means FOBs can be very similar to the original drug, but it’s not possible to be identical. FOBs may even be effective for use but they are not interchangeable with the original because they are not identical.

This is true of both carbohydrate-based and protein-based biologics and the risk of not including both varieties of biologics in pending legislation could significantly jeopardize patient health and safety. As legislation advances through Congress, it’s important that the final version of any bill provide a comprehensive approval pathway for carbohydrate- and protein-based FOBs.

Americans spend more than $40 billion annually on biologic drugs and the goal of more affordable medicine is a national health priority — one that is a critical component of healthcare reform. But paramount in medicine is the health and safety of the patient, which demands a thoughtful and comprehensive approach to FOB approval including clinical testing.

This debate will have far-reaching implications with regard to safety, access, cost and therapeutic impact for thousands of patients with serious diseases and it is critical that the approval process for FOBs applies to all biologics, not just some.

Philadelphia


Unfair criticism of my tenure at Fannie Mae

From Jamie Gorelick, partner, WilmerHale law firm

Dick Morris tries to malign Sallie Mae’s attempts to help forge a solution for student lending by maligning me (column, “Student loans: Obama right,” April 15). As is so often the case, Morris is full of bluster but short on facts.

It is wearying to have to set the record straight on matters that have been corrected before, but here goes: When I left Fannie Mae in early 2003 to join the 9/11 Commission, there were very few subprime loans on Fannie Mae’s books, and none of the Alt-A loans, purchased in 2007 and 2008, which were the primary cause of Fannie Mae’s problems. The book of business that Fannie Mae took on some years after I left, and their causal relationship to Fannie Mae’s financial problems, have been fully described by The New York Times and the American Educational Institute.

When Morris says Fannie Mae “piled up billions in subprime lending obligations” during my tenure, he is, to put it politely, talking through his hat. During my tenure with the company, Fannie Mae’s lending standards were prudent and thoughtful, fulfilling both its mission and its responsibilities to shareholders.

Morris repeats the discredited charge of former Attorney General John Ashcroft that Clinton Justice Department policies prevented the FBI from doing its job before 9/11. The 9/11 Commission (without my participation on this issue) rejected Ashcroft’s testimony as not fair or accurate and noted that it was Ashcroft’s own department policies that were in effect in the run-up to 9/11.

Finally, I should note that Morris’s entire premise is similarly wrong. I have not been hired by lenders to lobby against the president’s student loan program. Rather, I — and my sole client, Sallie Mae — support the central goal of the president’s program, which is to reap the benefit of switching from lender to government funding of loans in order to generate substantial funds for Pell Grants. Sallie Mae would like to do so while permitting lenders to still supply services on a fee basis to schools and students.

There are lenders who oppose the president’s goals, but Sallie Mae does not.

Washington