[Ip-health] language in the ACA on biologics Re: Will USTR undermine Obama on biosimilars at Trans-Pacific trade negotiations?

Ruth Lopert ruth.lopert at gmail.com
Fri May 27 21:24:36 PDT 2011


Sorry Ellen but what's your point?

On Sat, May 28, 2011 at 12:15 AM, Ellen Shaffer <ershaffer at gmail.com> wrote:

>  I believe this is it:
>
> *751 PPACA (Consolidated) Sec. 7002*
> *SEC. 7002. APPROVAL PATHWAY FOR BIOSIMILAR BIOLOGICAL PRODUCTS.*
>
> *(a) L*
> *ICENSURE OF BIOLOGICAL PRODUCTS AS BIOSIMILAR OR*
>
> *I*
> *NTERCHANGEABLE**.—Section 351 of the Public Health Service Act*
>
> *(42 U.S.C. 262) is amended—*
>
> (1) in subsection (a)(1)(A), by inserting ‘‘under this subsection
>
> or subsection (k)’’ after ‘‘biologics license’’; and
>
> (2) by adding at the end the following:
>
> ‘‘(k) L
> ICENSURE OF BIOLOGICAL PRODUCTS AS BIOSIMILAR OR
>
> I
> NTERCHANGEABLE.—
>
> ‘‘(1) I
> N GENERAL.—Any person may submit an application
>
> for licensure of a biological product under this subsection.
>
> ‘‘(2) C
> ONTENT.—
>
> ‘‘(A) I
> N GENERAL.—
>
> ‘‘(i) R
> EQUIRED INFORMATION.—An application submitted
>
> under this subsection shall include information
>
> demonstrating that—
>
> ‘‘(I) the biological product is biosimilar to a
>
> reference product based upon data derived from—
>
> ‘‘(aa) analytical studies that demonstrate
>
> that the biological product is highly similar to
>
> the reference product notwithstanding minor
>
> differences in clinically inactive components;
>
> ‘‘(bb) animal studies (including the assessment
>
> of toxicity); and
>
> ‘‘(cc) a clinical study or studies (including
>
> the assessment of immunogenicity and pharmacokinetics
>
> or pharmacodynamics) that are
>
> sufficient to demonstrate safety, purity, and
>
> potency in 1 or more appropriate conditions of
>
> use for which the reference product is licensed
>
> and intended to be used and for which licensure
>
> is sought for the biological product;
>
> ‘‘(II) the biological product and reference product
>
> utilize the same mechanism or mechanisms of
>
> action for the condition or conditions of use prescribed,
>
> recommended, or suggested in the proposed
>
> labeling, but only to the extent the mechanism
>
> or mechanisms of action are known for the
>
> reference product;
>
> VerDate 0ct 09 2002 13:03 Jun 09, 2010 Jkt 000000 PO 00000 Frm 00747 Fmt
> 9001 Sfmt 6601 F:\P11\NHI\COMP\PPACACON.005 HOLCPC
> *Sec. 7002 PPACA (Consolidated) 748*
>
> ‘‘(III) the condition or conditions of use prescribed,
>
> recommended, or suggested in the labeling
>
> proposed for the biological product have been
>
> previously approved for the reference product;
>
> ‘‘(IV) the route of administration, the dosage
>
> form, and the strength of the biological product
>
> are the same as those of the reference product;
>
> and
>
> ‘‘(V) the facility in which the biological product
>
> is manufactured, processed, packed, or held
>
> meets standards designed to assure that the biological
>
> product continues to be safe, pure, and potent.
>
> ‘‘(ii) D
> ETERMINATION BY SECRETARY.—The Secretary
>
> may determine, in the Secretary’s discretion,
>
> that an element described in clause (i)(I) is unnecessary
>
> in an application submitted under this subsection.
>
> ‘‘(iii) A
> DDITIONAL INFORMATION.—An application
>
> submitted under this subsection—
>
> ‘‘(I) shall include publicly-available information
>
> regarding the Secretary’s previous determination
>
> that the reference product is safe, pure, and
>
> potent; and
>
> ‘‘(II) may include any additional information
>
> in support of the application, including publiclyavailable
>
> information with respect to the reference
>
> product or another biological product.
>
> ‘‘(B) I
> NTERCHANGEABILITY.—An application (or a supplement
>
> to an application) submitted under this subsection
>
> may include information demonstrating that the biological
>
> product meets the standards described in paragraph (4).
>
> ‘‘(3) E
> VALUATION BY SECRETARY.—Upon review of an application
>
> (or a supplement to an application) submitted under this
>
> subsection, the Secretary shall license the biological product
>
> under this subsection if—
>
> ‘‘(A) the Secretary determines that the information
>
> submitted in the application (or the supplement) is sufficient
>
> to show that the biological product—
>
> ‘‘(i) is biosimilar to the reference product; or
>
> ‘‘(ii) meets the standards described in paragraph
>
> (4), and therefore is interchangeable with the reference
>
> product; and
>
> ‘‘(B) the applicant (or other appropriate person) consents
>
> to the inspection of the facility that is the subject of
>
> the application, in accordance with subsection (c).
>
> ‘‘(4) S
> AFETY STANDARDS FOR DETERMINING INTERCHANGEABILITY.—
>
> Upon review of an application submitted under this
>
> subsection or any supplement to such application, the Secretary
>
> shall determine the biological product to be interchangeable
>
> with the reference product if the Secretary determines
>
> that the information submitted in the application (or a supplement
>
> to such application) is sufficient to show that—
>
> ‘‘(A) the biological product—
> VerDate 0ct 09 2002 13:03 Jun 09, 2010 Jkt 000000 PO 00000 Frm 00748 Fmt
> 9001 Sfmt 6601 F:\P11\NHI\COMP\PPACACON.
> ‘‘(i) is biosimilar to the reference product; and
>
> ‘‘(ii) can be expected to produce the same clinical
>
> result as the reference product in any given patient;
>
> and
>
> ‘‘(B) for a biological product that is administered more
>
> than once to an individual, the risk in terms of safety or
>
> diminished efficacy of alternating or switching between
>
> use of the biological product and the reference product is
>
> not greater than the risk of using the reference product
>
> without such alternation or switch.
>
> ‘‘(5) G
> ENERAL RULES.—
>
> ‘‘(A) O
> NE REFERENCE PRODUCT PER APPLICATION.—A
>
> biological product, in an application submitted under this
>
> subsection, may not be evaluated against more than 1 reference
>
> product.
>
> ‘‘(B) R
> EVIEW.—An application submitted under this
>
> subsection shall be reviewed by the division within the
>
> Food and Drug Administration that is responsible for the
>
> review and approval of the application under which the
>
> reference product is licensed.
>
> ‘‘(C) R
> ISK EVALUATION AND MITIGATION STRATEGIES.—
>
> The authority of the Secretary with respect to risk evaluation
>
> and mitigation strategies under the Federal Food,
>
> Drug, and Cosmetic Act shall apply to biological products
>
> licensed under this subsection in the same manner as such
>
> authority applies to biological products licensed under subsection
>
> (a).
>
> ‘‘(6) E
> XCLUSIVITY FOR FIRST INTERCHANGEABLE BIOLOGICAL
>
> PRODUCT
> .—Upon review of an application submitted under this
>
> subsection relying on the same reference product for which a
>
> prior biological product has received a determination of interchangeability
>
> for any condition of use, *the Secretary shall not*
>
> *make a determination under paragraph (4) that the second or*
>
> *subsequent biological product is interchangeable for any condition*
>
> *of use until the earlier of—*
>
> *‘‘(A) 1 year after the first commercial marketing of the*
>
> *first interchangeable biosimilar biological product to be approved*
>
> *as interchangeable for that reference product;*
>
> *‘‘(B) 18 months after—*
>
> *‘‘(i) a final court decision on all patents* *in suit in*
>
> *an action instituted under subsection (l)(6) against the*
>
> *applicant that submitted the application for the first*
>
> *approved interchangeable biosimilar biological product;*
>
> *or*
>
> *‘‘(ii) the dismissal with or without prejudice of an*
>
> *action instituted under subsection (l)(6) against the*
>
> *applicant that submitted the application for the first*
>
> *approved interchangeable biosimilar biological product;*
>
> *or*
>
> *‘‘(C)(i) 42 months after approval of the first interchangeable*
>
> *biosimilar biological product if the applicant*
>
> *that submitted such application has been sued under subsection*
>
> *(l)(6) and such litigation is still ongoing within*
>
> *such 42-month period; or*
>
> *VerDate 0ct 09 2002 13:03 Jun 09, 2010 Jkt 000000 PO 00000 Frm 00749 Fmt
> 9001 Sfmt 6601 F:\P11\NHI\COMP\PPACHOLCPC*
> **
> *‘‘(ii) 18 months after approval of the first interchangeable*
>
> *biosimilar biological product if the applicant that submitted*
>
> *such application has not been sued under subsection*
>
> (l)(6).
>
> For purposes of this paragraph, the term ‘final court decision’
>
> means a final decision of a court from which no appeal (other
>
> than a petition to the United States Supreme Court for a writ
>
> of certiorari) has been or can be taken.
>
> *‘‘(7) E*
> *XCLUSIVITY FOR REFERENCE PRODUCT**.—*
>
> *‘‘(A) E*
> *FFECTIVE DATE OF BIOSIMILAR APPLICATION APPROVAL**.—*
>
> *Approval of an application under this subsection*
>
> *may not be made effective by the Secretary until the date*
>
> *that is 12 years after the date on which the reference product*
>
> *was first licensed under subsection (a).*
>
> ‘‘(B) F
> ILING PERIOD.—An application under this subsection
>
> may not be submitted to the Secretary until the
>
> date that is 4 years after the date on which the reference
>
> product was first licensed under subsection (a).
>
> ‘‘(C) F
> IRST LICENSURE.—Subparagraphs (A) and (B)
>
> shall not apply to a license for or approval of—
>
> ‘‘(i) a supplement for the biological product that is
>
> the reference product; or
>
> ‘‘(ii) a subsequent application filed by the same
>
> sponsor or manufacturer of the biological product that
>
> is the reference product (or a licensor, predecessor in
>
> interest, or other related entity) for—
>
> ‘‘(I) a change (not including a modification to
>
> the structure of the biological product) that results
>
> in a new indication, route of administration, dosing
>
> schedule, dosage form, delivery system, delivery
>
> device, or strength; or
>
> ‘‘(II) a modification to the structure of the biological
>
> product that does not result in a change in
>
> safety, purity, or potency.
>
> ‘‘(8) G
> UIDANCE DOCUMENTS.—
>
> ‘‘(A) I
> N GENERAL.—The Secretary may, after opportunity
>
> for public comment, issue guidance in accordance,
>
> except as provided in subparagraph (B)(i), with section
>
> 701(h) of the Federal Food, Drug, and Cosmetic Act with
>
> respect to the licensure of a biological product under this
>
> subsection. Any such guidance may be general or specific.
>
> ‘‘(B) P
> UBLIC COMMENT.—
>
> ‘‘(i) I
> N GENERAL.—The Secretary shall provide the
>
> public an opportunity to comment on any proposed
>
> guidance issued under subparagraph (A) before
>
> issuing final guidance.
>
> ‘‘(ii) I
> NPUT REGARDING MOST VALUABLE GUIDANCE.—
>
> The Secretary shall establish a process
>
> through which the public may provide the Secretary
>
> with input regarding priorities for issuing guidance.
>
> ‘‘(C) N
> O REQUIREMENT FOR APPLICATION CONSIDERATION.—
>
> The issuance (or non-issuance) of guidance under
>
> subparagraph (A) shall not preclude the review of, or action
>
> on, an application submitted under this subsection.
>
> VerDate 0ct 09 2002 13:03 Jun 09, 2010 Jkt 000000 PO 00000 Frm 00750 Fmt
> 9001 Sfmt 6601 F:\P11\NHI\COMP\PPACACON.005
>
> ‘‘(D) R
> EQUIREMENT FOR PRODUCT CLASS-SPECIFIC GUIDANCE.—
>
> If the Secretary issues product class-specific guidance
>
> under subparagraph (A), such guidance shall include
>
> a description of—
>
> ‘‘(i) the criteria that the Secretary will use to determine
>
> whether a biological product is highly similar
>
> to a reference product in such product class; and
>
> ‘‘(ii) the criteria, if available, that the Secretary
>
> will use to determine whether a biological product
>
> meets the standards described in paragraph (4).
>
> ‘‘(E) C
> ERTAIN PRODUCT CLASSES.—
>
> ‘‘(i) G
> UIDANCE.—The Secretary may indicate in a
>
> guidance document that the science and experience, as
>
> of the date of such guidance, with respect to a product
>
> or product class (not including any recombinant protein)
>
> does not allow approval of an application for a license
>
> as provided under this subsection for such product
>
> or product class.
>
> ‘‘(ii) M
> ODIFICATION OR REVERSAL.—The Secretary
>
> may issue a subsequent guidance document under
>
> subparagraph (A) to modify or reverse a guidance document
>
> under clause (i).
>
> ‘‘(iii) N
> O EFFECT ON ABILITY TO DENY LICENSE.—
>
> Clause (i) shall not be construed to require the Secretary
>
> to approve a product with respect to which the
>
> Secretary has not indicated in a guidance document
>
> that the science and experience, as described in clause
>
> (i), does not allow approval of such an application.
>
> ‘‘(l) P
> ATENTS.—
>
> ‘‘(1) C
> ONFIDENTIAL ACCESS TO SUBSECTION (k) APPLICATION
>
> On Fri, May 27, 2011 at 8:37 PM, Ruth Lopert <ruth.lopert at gmail.com>wrote:
>
>> Oh my. Actually the PPACA provides only 4 years of data exclusivity, but
>> 12
>> years of market exclusivity (12 years of data exclusivity would be even
>> worse)  And they are not patent protections. And the exclusivity applies
>> to
>> the originator, not the biosimilar.
>>
>> And they wont get it anyway.
>>
>> RL
>>
>> On Fri, May 27, 2011 at 4:08 PM, Peter Maybarduk <pmaybarduk at citizen.org
>> >wrote:
>>
>> > Inside U.S. Trade - 05/27/2011
>> > USTR Signals Support For Longer Data Protection For Biologics In TPP
>> > Posted: May 26, 2011
>> > The Office of the U.S. Trade Representative signaled last week it will
>> > pursue stronger patent protections for biosimilar drugs than for
>> > conventional medicines in the Trans-Pacific Partnership (TPP)
>> negotiations,
>> > as demanded by U.S. pharmaceutical companies, according to informed
>> sources.
>> >
>> > In a May 20 briefing for private-sector stakeholders, USTR officials
>> > indicated they may propose granting as much as 12 years of data
>> exclusivity
>> > for biosimilar drugs -- also known as biologics -- these sources said.
>> The
>> > officials, however, did not fully commit to doing so, they said.
>> >
>> > A 12-year data exclusivity period would reflect provisions in the U.S.
>> > health care reform bill that was signed into law last year. At the same
>> > time, the officials said they were aware of the fact that President
>> Obama's
>> > fiscal year 2012 budget proposal called for a reduction of the data
>> > exclusivity period for biologics to seven years.
>> >
>> > Either of these periods would be a jump up from the five years of data
>> > exclusivity for pharmaceuticals that the United States has negotiated in
>> > past trade deals.
>> >
>> > During the data exclusivity period, generic drug manufacturers are
>> barred
>> > from accessing the clinical data typically generated by brand-name drug
>> > companies. This delays the marketing of cheaper, generic competitor
>> drugs.
>> >
>> > The Pharmaceutical Research and Manufacturers of America (PhRMA), the
>> > Biotechnology Industry Organization (BIO) and others are urging USTR to
>> > secure 12 years of data exclusivity for biologics in the TPP talks in
>> order
>> > to match the provisions of U.S. law (Inside U.S. Trade, April 29).
>> >
>> > "We seek reciprocity in trade agreements," said Lila Feisee, vice
>> president
>> > of global intellectual property at the Biotechnology Industry
>> Organization.
>> > "There should be reciprocity in our trade partners as well."
>> >
>> > This would mean the eight other TPP parties would be expected to adopt
>> the
>> > same 12-year data exclusivity period for biologics.
>> >
>> > A private-sector source pointed out that the negotiating objectives in
>> the
>> > 2002 fast-track law, which has expired, states that negotiators should
>> > ensure that any IPR measure should "reflect a standard of protection
>> similar
>> > to that found in United States law."
>> >
>> > The USTR officials in the briefing did not say for certain whether the
>> > United States will table a complete proposal on intellectual property
>> rights
>> > (IPR) before the next round of TPP negotiations in Vietnam scheduled for
>> > mid-June, but signaled that they are working toward this goal, at least
>> with
>> > respect to pharmaceutical patent provisions, sources said.
>> >
>> > In a related development, Assistant USTR for IPR Stan McCoy did not
>> commit
>> > to making a complete IPR proposal by the Vietnam round. At a May 16
>> event,
>> > he said it is difficult "to say with certainty what we're going to do
>> when."
>> >
>> > "The next round will be in Vietnam and we're looking at what we can
>> table
>> > for that round and it's all kind of an ongoing process inside the
>> > administration," McCoy said. USTR has already tabled most of its
>> proposed
>> > IPR text, but has not yet tabled the most crucial provisions on patent
>> > protections and other IPR topics.
>> >
>> > At the briefing, one USTR official made it "very clear" that the U.S.
>> > government does not intend to replicate the patent provisions in the May
>> 10
>> > agreement, one informed source said. That agreement, struck in 2007
>> between
>> > House Democrats and the Bush administration, eased requirements for data
>> > exclusivity for conventional drugs, patent linkage and patent term
>> extension
>> > in the FTAs with Panama, Peru and Colombia to improve access for
>> affordable
>> > medicines.
>> >
>> > The official said that "2007 was 2007," and "2011 is 2011," in an
>> apparent
>> > signal that the 2007 deal as negotiated is not directly relevant for the
>> TPP
>> > deal, sources said.
>> >
>> > For instance, USTR noted that new domestic legislation, such as the
>> health
>> > care reform bill establishing a 12-year data exclusivity for biologics,
>> is
>> > one example of how the circumstances differ now when considering whether
>> the
>> > May 10 standards are still relevant for TPP, sources said.
>> >
>> > The pharmaceutical industry has launched a major lobbying campaign to
>> get
>> > USTR to disregard the May 10 deal and make the U.S.-Korea FTA the basis
>> of
>> > its TPP proposals on pharmaceuticals (Inside U.S. Trade, April 29).
>> >
>> > In the briefing, USTR said that it has not yet tabled text on
>> > pharmaceutical pricing and reimbursement policies, but said it is under
>> > consideration. But USTR gave no clues on whether such provisions would
>> stand
>> > as a separate chapter or if they would be included in other chapters,
>> > sources said.
>> >
>> > Industry wants these provisions to be included as a way to mandate more
>> > transparency for or altogether counteract national drug pricing
>> programs,
>> > which they say can restrict market access and profits for U.S. drug
>> > companies.
>> >
>> > _______________________________________________
>> > Ip-health mailing list
>> > Ip-health at lists.keionline.org
>> >
>> http://lists.keionline.org/mailman/listinfo/ip-health_lists.keionline.org
>> >
>> _______________________________________________
>> Ip-health mailing list
>> Ip-health at lists.keionline.org
>> http://lists.keionline.org/mailman/listinfo/ip-health_lists.keionline.org
>>
>
>
>
> --
> Ellen R. Shaffer, PhD MPH
> Co-Director, Center for Policy Analysis/EQUAL/CPATH
> San Francisco Presidio
> P.O. Box 29586
> San Francisco, CA 94129-0586
> Phone 415-922-6204
> www.centerforpolicyanalysis.org
> www.cpath.org
> cell: 415-680-4603
>
>



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