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Page 1: A Dangerous Loophole in the Process for FDA Approval of ... · PDF fileA Dangerous Loophole in the Process for FDA Approval of New Tobacco Products ... without FDA authorization and

Premarket Review of Tobacco Products / 1

FDA Tobacco Project

A Dangerous Loophole in the Process for FDA Approval of

New Tobacco Products

The Family Smoking Prevention and Tobacco Control Act gives the U.S. Food and Drug

Administration unprecedented authority to regulate tobacco products.1 One of the most powerful

tools available to the FDA under the Tobacco Control Act is to decide whether or not a new

tobacco product can be introduced to the market.2 In theory, this gatekeeping role for the FDA

should allow it to prevent those products with the most potential to harm public health from ever

making it to retail store shelves.

However, the tobacco industry has exploited a loophole that allowed it to introduce thousands of

new addictive and deadly products without FDA authorization and the FDA has done very little

thus far to stop this manipulation. In fact, while the FDA has publicized its actions on some

product applications, it has failed to prioritize the removal of non-compliant, loophole-exploiting

products from the market. At the same time, it has continued to authorize new products for sale,

allowing the tobacco product market to grow.

This problem is mostly hidden from the public health community. The FDA has not made it a

priority to explain the fairly technical application approval process – or how the agency is

implementing this process – in sufficient depth, using terms that the general public can

understand. This fact sheet will explain the process for authorizing the marketing of new

products and provide information on FDA’s actions to date.

FDA Authority over New Products

The Tobacco Control Act creates three pathways by which the tobacco industry can receive FDA

authorization to put additional products on the market: 1) Premarket Tobacco Product

Applications, 2) Substantial Equivalence Reports, and 3) Exemptions from Substantial

Equivalence Reports. Each pathway has its own review process.

1) Premarket Tobacco Product Applications (PMTA)

The “Premarket Tobacco Product Application” pathway for new products is what most would

imagine when they learn that the Tobacco Control Act requires the FDA to decide whether or not

new products can enter the market. The FDA often refers to the pathway by the acronym,

“PMTA.” The pathway is intended to be the primary process for the FDA to decide whether it is

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Premarket Review of Tobacco Products / 2

appropriate for new tobacco products to enter the market. This pathway should be used for any

products that are different from all other products marketed before February 15, 2007. An

application should be denied by the FDA if: 1) the product does not appropriately protect public

health,3 considering the product’s impact on initiation and cessation;

4 2) the manufacturing

process for the product does not meet established standards;5 3) the labeling of the product is

false or misleading;6 or 4) the product does not meet a product standard set by the FDA.

7

Little information is available regarding how the FDA reviews these applications because the

tobacco industry did not submit any applications of this type until August 2013 and then only

submitted four.8 The FDA had 180 days to approve or deny these applications,

9 and in February

2014, the agency announced that it rejected the submissions because they were deficient.10

Because they were rejected and could be modified and then resubmitted, the FDA did not

disclose their contents.

2) Substantial Equivalence Reports (SE)

The “Substantial Equivalence Report” pathway, or the “SE” pathway, is the review process for

new products that are similar to products already on the market. This process is intended to be

used for products that have the same characteristics as products marketed as of February 15,

2007,11

or that have different characteristics that do not raise different questions of public

health.12

This product pathway requires a comparison between an existing product, which the FDA calls a

predicate product, and the new product yet to be marketed. If the FDA finds that the existing

product was commercially marketed (not test marketed) in the United States on February 15,

2007, it can be named as a predicate product on this type of application.13

A product that is

authorized for sale under this pathway can also serve as a predicate product on another

application even if the authorized product was not on the market until after February 15, 2007, as

long as the product is compliant with any product standards established by the FDA.14

3) Substantial Equivalence Exemption (SE Exemption)

The third method the industry can use to seek FDA authorization a new product is to file a

request for exemption from Substantial Equivalence stating that, for example,15

a new product is

so similar to a predicate product (described above) that the difference between the two is minor

and the submission of a full report demonstrating substantial equivalence is not necessary to

protect public health.16

The Tobacco Control Act provides an example of a product that might be

exempt from the SE report process: a product that is only different from an existing product

because an additive was deleted or added or where the level of an existing additive was increased

or decreased.17

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Premarket Review of Tobacco Products / 3

Figure 1.

The Loophole that Allows Thousands of Products to Avoid Premarket Review

Under the first and third pathways listed above – the pathways for products that are entirely

different from products already on the market (PMTA) or for the products that the industry

claims should be exempt from the SE report process due to their similarity to products already on

the market (SE Exemption) – no products can be introduced to the market until after the FDA

has reviewed and approved the industry’s applications.

Similarly, for any industry applications filed after March 22, 2011, under the second pathway –

seeking FDA approval to sell new tobacco products because they are similar to other products

already on the market (SE) – the new products cannot be sold until the FDA grants permission.

However, industry applications that were filed under the SE pathway by March 22, 2011 are

treated differently. The Tobacco Control Act states that the new products listed in these

Premarket Tobacco Product

Application (PMTA)

Substantial Equivalence (SE)

Substantial Equivalence

Exemption (SE Exemption)

Greatest

Potential to Affect Public Health

Rigor of Scientific Review

Greatest

Greatest

Least

Least

Least

Uniqueness of Product as Compared to Products

Already on the Market

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Premarket Review of Tobacco Products / 4

applications can be introduced to the market and stay on the market until the FDA reviews the

applications and decides to require that the product be removed from the market. The

applications that fall within this category are called “Provisional Substantial Equivalence” or

“Provisional SE” reports, all other SE reports are called “Regular” SE reports.

With its sophisticated knowledge of the Tobacco Control Act and instinct for profit-seeking at

the expense of public health, the tobacco industry orchestrated a massive exploitation of this

loophole in the new product authorization process. The industry flooded the FDA with

Provisional SE reports just before the March 22, 2011 deadline, bringing the total number of

Provisional SE reports to 3,517.18

This activity is striking considering that the industry filed only

959 Regular SE reports after March 22, 2011,19

and only 63 total product applications under the

pathways that are entirely subject to premarket review (4 PMTAs and 59 SE Exemption

requests).20

This means that 77% of the 4,539 applications that the FDA has received to allow

new products to enter the market were submitted through the loophole that allows the industry to

sell the products before they can be reviewed by the FDA.21

Figure 2 attempts to put this tactic

into perspective.

Figure 2.

While the FDA publicizes its actions on pending SE reports, even considering the actions taken

on Regular SE reports, the total amount of FDA action in the context of all SE reports is very

small. The agency’s action with respect to Provisional SE reports is even smaller. In the four

years since the vast majority of the Provisional SE reports were submitted, the FDA has only

acted on 11 Provisional SE reports.22

After 181 industry withdrawals, 3,325 reports remain,

representing products that can be sold to consumers even though they have not been subject to

any federal oversight. In addition, only 142 of these reports are currently under scientific

4

959

3,517

59 Tobacco Product Applications

PMTA(preapproval required)

Regular SE(preapproval required)

Provisional SE(can enter the marketwithout preapproval)SE Exempt(preapproval required)

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Premarket Review of Tobacco Products / 5

review.23

The FDA’s stated commitment to prioritizing Regular rather than Provisional SE

reports perpetuates this problem caused by the loophole.24

Figure 3 shows FDA action for

Regular and Provisional SE reports separately as well as all both categories combined.25

Figure 3.

Because Regular SE reports represent products that are not yet on the market, delayed review of

these reports poses no threat to public health. However, delaying action on Provisional SE

reports, as the FDA continues to commit to doing, allows the tobacco industry to continue to sell

deadly and addictive products that have not been scrutinized by the FDA.

The Proposed Deeming Regulation Multiplies the Problem

The public health threat caused by the FDA’s continued delay on Provisional SE reports will be

multiplied if the FDA finalizes the Deeming Regulation as it is currently proposed.26

The

proposed regulation will bring additional classes of tobacco products under the FDA’s regulatory

authority. According to the agency’s proposal, the FDA expects to receive 54 PMTAs, 4,208 SE

reports, and 1,402 SE Exemption requests in the first two years after the regulation takes effect.27

These estimates may be low because the FDA expects that the regulation will result in over

13,000 new products being brought under its authority and long delays in the finalization and

implementation of this rule will allow more tobacco products to be introduced in the interim. All

of these new product applications will need to be reviewed, as will the FDA’s existing backlog

of applications. That problem cannot be avoided.

11 181

3,325

Provisional SE Reports - 3,517 total

(can enter the market without preapproval)

133

305 521

Regular SE Reports - 959 total (preapproval required)

FDA Action(denial, approval, or refusal to accept)

Industry Withdrawals Pending Reports

144

486

3,846

All SE Reports - 4,476 total

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Premarket Review of Tobacco Products / 6

However, the FDA has proposed to defer enforcement of premarket review of all new products

that would now fall within its jurisdiction – regardless of the pathway – for 24 months following

the regulation’s implementation. While a delay in the FDA’s approval or denial of the sale of

new products may not normally be a grave concern of the public health community, the FDA

proposes to establish that 24-month window as a new provisional period, meaning that the FDA

would allow the tobacco industry to market even more new products until the FDA reviews the

applications for those products and decides whether to order the products removed from the

market.

The FDA can solve this problem and best protect public health by taking two steps. First, it must

prioritize its review of existing Provisional SE reports filed under the loophole created by the

Tobacco Control Act. Second, the FDA’s Deeming Regulation must not create another loophole

in the premarket review process by allowing a provisional period for new tobacco product

applications for the products that will fall under its jurisdiction in the future.

For more in-depth information on the FDA’s review of tobacco product marketing applications,

see the Consortium’s Tobacco Product Applications webpage with other resources on this topic,

including our FDA Premarket Review Video Series.

Last updated: April 2015

The Tobacco Control Legal Consortium provides information and technical assistance on issues

related to tobacco and public health. The Consortium does not provide legal representation or

advice. This document should not be considered legal advice or a substitute for obtaining legal

advice from an attorney who can represent you. If you have specific legal questions,

we recommend that you consult with an attorney familiar with the laws of your jurisdiction.

Notes 1 Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111–31, 123 Stat. 1776 (2009)

(codified at 21 U.S.C. § 387). 2 21 U.S.C. § 387j.

3 21 U.S.C. § 387j(c)(2)(A).

4 21 U.S.C. § 387j(c)(4).

5 21 U.S.C. § 387j(c)(2)(B).

6 21 U.S.C. § 387j(c)(2)(C).

7 21 U.S.C. § 387j(c)(2)(D).

8 U.S. FOOD AND DRUG ADMIN., Total Number of Product Submission Received or Filed in the Month,

http://www.accessdata.fda.gov/FDATrack/track?program=ctp&id=CTP-OS-total-product-submissions-received&fy=all (last visited December 3, 2014). 9 21 U.S.C. § 387j(c)(1)(A).

10 U.S. FOOD AND DRUG ADMIN., Tobacco Product Marketing Orders,

http://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/ucm339928.htm (last visited

December 3, 2014); U.S. FOOD AND DRUG ADMIN., Brief Summary of “Refusal-to-File” Determinations,

http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UCM389515.pdf

(last visited May 13, 2014).

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11

21 U.S.C. § 387j(a)(3)(A)(i). 12

21 U.S.C. § 387j(a)(3)(A)(ii). 13

21 U.S.C. § 387e(j)(1)(A)(i). 14

21 U.S.C. § 387e(j)(1)(A)(i). 15

An applicant may also indicate that a report “is not necessary to ensure that permitting the tobacco

product to be marketed would be appropriate for protection of the public health,” or that “an exemption is otherwise appropriate.” 21 U.S.C. § 387e(j)(3)(A)(ii)-(iii). 16

21 U.S.C. § 387e(j)(3). 17

21 U.S.C. § 387e(j)(3). 18

U.S. FOOD AND DRUG ADMIN., Cumulative Number of Substantial Equivalence (SE) Provisional

Reports Received, http://www.accessdata.fda.gov/FDATrack/track?program=ctp&id=CTP-OS-provisional-SE-reports&fy=all (last visited December 3, 2014). 19

Id. 20

U.S. FOOD AND DRUG ADMIN., Total Number of Product Submission Received or Filed in the Month,

http://www.accessdata.fda.gov/FDATrack/track?program=ctp&id=CTP-OS-total-product-submissions-

received&fy=all (last visited December 3, 2014). All application totals current through September 30, 2014. 21

Id. 22

U.S. FOOD AND DRUG ADMIN., FDA News Release, FDA Issues First Orders to Stop Sale, Distribution

of Tobacco Products, Feb. 21, 2014,

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm386707.htm (last visited

December 3, 2014). 23

U.S. FOOD AND DRUG ADMIN., Cumulative Number of Substantial Equivalence (SE) Provisional

reports received, http://www.accessdata.fda.gov/FDATrack/track?program=ctp&id=CTP-OS-provisional-SE-reports&fy=all (last visited December 3, 2014). 24

See, e.g., U.S. FOOD AND DRUG ADMIN., TOBACCO PRODUCTS, WEBINARS, April 10, 2013, available at

http://www.fda.gov/TobaccoProducts/Labeling/TobaccoProductReviewEvaluation/NewTobaccoProductR

eviewandEvaluation/SubstantialEquivalence/ucm304518.htm; U.S. FOOD AND DRUG ADMIN., TOBACCO

PRODUCTS, WEBINARS, April 24, 2012, available at

http://www.fda.gov/TobaccoProducts/Labeling/TobaccoProductReviewEvaluation/NewTobaccoProductR

eviewandEvaluation/SubstantialEquivalence/ucm304518.htm; U.S. FOOD AND DRUG ADMIN., TOBACCO

PRODUCTS, WEBINARS, August 21, 2012, available at

http://www.fda.gov/TobaccoProducts/Labeling/TobaccoProductReviewEvaluation/NewTobaccoProductReviewandEvaluation/SubstantialEquivalence/ucm304518.htm. 25

FDA data on incoming applications is current through September 30, 2014, while the number of

industry withdrawals and FDA actions is current through November 30, 2014. 26

Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended

by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of

Tobacco Products and Required Warning Statements for Tobacco Products; Proposed Rule, 79 Fed. Reg.

23,142 (proposed April 25, 2014) (to be codified at 21 C.F.R. pt. 1100, 1140, and 1143); see also

Tobacco Control Legal Consortium, FDA Takes Small Steps to Expand Tobacco Regulation (2014),

available at http://publichealthlawcenter.org/sites/default/files/resources/tclc-fs-fda-

takesmallstepexpandtobaccoregulation-2014.pdf. For more information regarding the FDA’s proposed

Deeming Regulation, see the Consortium’s FDA Tobacco Action Center webpage about the FDA’s

regulation of other tobacco products. 27

Id.